Clinical Research Associate Jobs

Job Title: Clinical Research Specialist Company: MedFocus Pharm. Res.Opp. Location: Minneapolis, MN Description: RESEARCH SPECIALISTCOMPANY INFO:MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.Our client makes it possible for millions of people to resume everyday activities, return to work, and live better, longer and is seeking to add a Research Specialist/CRA to their team in Minnesota.RESPONSIBILITIES:•    CRA will work closely with the CTL to satisfy applicable clinical and regulatory requirements and internal requirements for clinical studies•    Focuses on assigned areas of clinical study management, and/or coordinates and conducts site monitoring (and oversight of CROs)•    Contribute to the successful conduct of assigned studies consistent with Research•    Development and Marketing plans•    This may include interfacing with representatives from key functional groups including Field Clinical Engineering, Field Clinical Research Associates, Research, Biostatistics, Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs and European Clinical Groups•    Responsible for writing plans, strategy, and guidelines and performing activities and generating reports for one or more significant subparts of the study including: monitoring, data management, adverse events, consent, deaths, protocol deviations, legal agreements, study training, patient informed consent, newsletters/correspondence, publication committee, and contract research organizations•    Assists in the development of the Clinical Investigation Plan, study budget and project schedule, study training materials, and study reports in consultation with the CTL and cross-functional team, and investigators•    Assists CTL in the development and/or delivery of study related presentations•    Performs investigator and project file reviews for clinical study teams•    Performs and/or provides oversight for CRF data review•    Critically evaluates data for clinical reports, including collaboration with the study statistician to run appropriate error checks and evaluate final analyses•    May participate in process improvement initiativesQUALIFICATIONS:•    Bachelor's degree in engineering, biological sciences or related medical/scientific field•    Knowledge of clinical research study processes and study design; ability to incorporate and adhere to GCPs and regulatory standards•    Some experience supporting clinical research or similar experience in a medical/scientific area•    Professional clinical research certification (e.g. ACRP, SoCRA) preferred•    Proficient knowledge of medical terminology•    Proficient knowledge in word processing, spreadsheets and database applications (e.g. MS Word and Excel)•    Knowledge of device operation and the ability to apply this knowledge to clinical study processes•    Ability to identify and implement solutions in addressing study issues•    Ability to cultivate relationships with customers and co-workers in a cross-functional environment•    Capable of clearly and effectively communicating verbally and in writing•    Ability to identify and adapt to shifting priorities and competing demands•    Ability to effectively interface with customers and coworkers•    Demonstrated ability to maintain composure in difficult circumstances•    High attention to detail and accuracyMedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.

Job Title: Senior Clinical Research Associate Company: Covance Inc. Location: Columbia, SC Description: Covance - Job details ("")'>   Job details   Business TitleSenior Clinical Research AssociateRequisition ID19785BRJob CategoryClinical ResearchLocationsColumbiaShift1Job PostingCOVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.About the Job• Site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures (SOPs), ICH Guidelines and Good Clinical Practice (GCP).• Site management responsibility for clinical studies according to Covance SOPs• To act in the project role of as Local Project Coordinator or Lead CRA as assigned.• Assures the implementation of project plans.• Assume line management responsibilities when requiredAbout You• Ideally a University/college degree (life science preferred) or certification in a related allied health profession.• Approximately three or more years of relevant clinical research experience in pharmaceutical or CRO industries• A thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements• Thorough knowledge of monitoring procedures we would like to hear from youWe OfferCovance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us!Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.Education/QualificationsRequired:• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology. In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.• Thorough understanding of the drug development process.• Fluent in local office language and in English, both written and verbal.Preferred:• Thorough knowledge of Covance S.O.P.s regarding site monitoring.ExperienceRequired:• Minimum of four (4) years (nothing less than four years will be considered) of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).• In lieu of the above requirements, candidates with > five (5) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) will be considered.• In lieu of the above requirements, candidates with four (4) years of site management and/or registry administration experience will be considered.• Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.• Excellent site monitoring skills.• Excellent study site management skills.• Excellent registry administration skills.• Ability to work with minimal supervision.• Good planning and organization skills.• Good computer skills with good working knowledge of a range of computer packages.• Excellent verbal and written communication skills.• Ability to train and supervise junior staff.• Ability to resolve project-related problems and prioritizes workload for self and team.• Ability to work within a project team.• Works efficiently and effectively in a matrix environment.Preferred: • One (1) or more year’s additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.• Local project coordination and/or project management.End timeN/ADays per week5 Index Monitor https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=20090&siteid=5090&AReq=19785BR&GQId=0 http://wrapguy.adicio.com/textjobs/jobs/covance_wkdiv/0b1f1af41defdd39a78bff492d72183a.html

Job Title: Dallas Based CRA Company: MedFocus Location: Dallas, TX Description: .ugDivBody_hj .ugFrame_hj .ugColWrap_hj .ugHeader_hj .ugHeadBot_hj .ugHeadBot_hj a:link .ugHeadBot_hj a:visited .ugHeadBot_hj a:hover, active .ugSeeLink_hj .ugLeftWrap_hj .ugLeftCol_hj .ugJobTitleLeft_hj .ugJobTitleLeft1_hj .ugLTable_hj .ugLHead_hj .ugLText_hj .ugMap_hj .ugMapplace_hj .ugRightWrap_hj .ugRightCol_hj .ugROver_hj .ugLeftLinks_hj a:link .ugBold_hj .ugRTitle1_hj .ugRtext_hj .ugFooter_hj .ugBanner_hj See all jobs at this company Job overview Company:  MedFocus Job Id:  Register to View Job Title:  Dallas Based CRA Location:  Dallas, TX Job Category:  Pharmaceutical/Biotech Position Type:  Full-Time, Contract Education:  Bachelor of Science Experience:  2-5 Years Experience Company overview Since 1993, MedFocus has succeeded in meeting the contract staffing needs of our consultants and clients faster and more effectively than our competition through "specialized" recruiting exclusively in the pharmaceutical arena. By staying focused, MedFocus has become the firm of choice for both client companies and our consultant job seekers. MedFocus is headquartered in Chicago, IL and has offices in Philadelphia, PA and San Francisco, CA. Learn More about MedFocus Company Website About Us Dallas Based CRA Job Description REGIONAL CRACOMPANY INFO:MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.Our client is a company that wants to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life and is seeking to add a Regional CRA to their Oncology team in Dallas, TX.RESPONSIBILITIES:• This person will be completely accountable for drug accountability and the site management of each site for which they are responsible. • Management and tracking of entire medication supply chain from issue to destruction. • Full integrated reporting of drug accountability, reconciliation, returns and destruction. • They must be able to operate a home-based office and be fully functional as a home-based monitor. Ability to travel 80+%.QUALIFICATIONS:• Candidates MUST have at least a Bachelor's degree in Health Sciences or licensed or certified health care training (i.e. RN) or equivalent experience.• Minimum of 1 years as a regional CRA/Monitor• Strong attention to detail and Medical Terminology required. • Ability to effectively communicate and complete accurate reports/forms, etc.• Oncology experience is a must. MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.font>

Job Title: Sr. CRA Company: Abraxis BioScience Location: Chicago, IL Description: Employer Information About Abraxis BioScience Abraxis BioScience is a fully integrated biotechnology company dedicated to delivering progressive therapeutics and core technologies that offer patients and medical professionals safer and more effective treatments for cancer and other critical illnesses. The Abraxis portfolio includes the world's first and only protein-based nanoparticle chemotherapeutic compound (ABRAXANE) which is based on its proprietary tumor targeting system known as the nab™ Technology platform. From the discovery and re....more info View all our jobs Job The purpose of this position is to perform all aspects of the clinical research monitoring process in accordance with GCP and Abraxis Standard Operating Procedures (SOPs). This role ensures the quality and integrity of Abraxis study data and ensures adequate protection of the rights and safety of human subjects in Abraxis sponsored clinical trials. This role will have increased expectations surrounding ability to lead teams, communicate and disseminate study-specific communications to team members and management. It will also have increased responsibilities surrounding study-specific strategic and document support activities. Key Skill sets & Activities Leadership & Team Player Strong Communication and Work Initiative Early identification of risks and collaborative mitigation Familiarity with Good Clinical Practices and regulatory requirements Familiar with concepts of clinical research and drug development General therapeutic area education and training (e.g. education, previous experience, nursing, medical) Strong knowledge base of site monitoring activities Ability to interpret protocol content and translate that knowledge as needed to site staff and colleagues Responsibilities • Site monitoring activities o Conduct Clinical Site Evaluation, Initiation, Maintenance and Close-out visits per Abraxis working practices and Standard Operating Procedures (SOPs) o Prepare accurate and timely monitoring visit reports o Identify, build and maintain quality research sites /investigators o Ensure Investigational Product (IP) is accounted for and reconciled o Collect, review and reconcile essential documents o Verify Case Reports and source documentation o Identify screening /enrollment barriers & partner with CTM to mitigate risks o Identify site needs and provide solutions to facilitate the clinical trial process o Verify ongoing suitability of investigators and sites throughout study conduct o Performs timely and accurate CTMS data entry per department training o Assists CTM in researching & confirming audit follow-up items o Perform essential duties as needed for trial objectives o Train and mentor new staff o Provide input into feasibility of protocols o Engage in Lead CRA monitoring activities, when assigned, including: ? Creation of Clinical Monitoring Plan ? Providing input into case report forms and study-related guides ? Co-monitoring & performing study-specific training for new staff as needed ? Assisting CTMs with trip report review as needed ? Facilitating communication of study related activities to study team • Department Expectations & Collaboration o Prepares accurate and timely expense reports o Plans work schedule to meet project timelines o Maintains timely and effective communication via written, oral, and/or electronic contacts o Completes all clinical corporate, and project specific training and attends staff and department meetings as required o Procure tools, systems, and training based on demonstrated business need o Escalates project, department, or corporate risk to management as appropriate o Participates in department teams, initiatives and taskforces as needed NOTES: Local Residents Preferred (No Relo)

Job Title: TEMP, Senior Clinical Research Associate Company: Stryker Biotech Location: Hopkinton, MA Description: With minimal direction, the Temp, SeniorClinical Project Manager, is responsible formanagement of all clinical aspects ofdomestic and international clinical trials toensure compliance with the ClinicalProtocol, Stryker Biotech StandardOperating Procedures (SOP’s), GoodClinical Practices (GCPs) and otherapplicable regulations. The CPM may alsobe responsible for the management anddevelopment of Clinical ResearchAssociates (I, II or III).•Manages multiple clinical trials within atherapeutic area.•Selects and assists in the qualification ofinvestigational clinical sites and vendors(e.g., CROs, Central Labs, CoreRadiographic Labs)•Assists in the preparation of the clinicalstudy budget and manages clinical study toapproved budget.•Oversees the preparation, review andapproval of study documents (e.g.,Protocol, CRF, Study Manual)•Assists with the interim and final reportingand data analysis of clinical trial results•Represents Clinical Operations function onStryker Biotech Project/Program teams•Manages sponsor clinical studyresponsibilities and communicates status toProject/Program Teams and Clinical Affairsmanagement REQUIREMENTS - QUALIFICATIONS: TEMP, Senior Clinical Research Associate •Experience in all conducting all clinicalresearch aspects – site selection,qualification, initiation, monitoring andcloseout•Experience in management of domesticand international clinical trials•Experience with vendor management andability to manage multiple vendors•Excellent written and oral communicationskills, as well as proficiency in MS Office(Word, Excel, Powerpoint)•Working knowledge of medicalterminology, ICH Guidelines, and U.S.regulations regarding conduct of clinicalstudies required•Detail-oriented, possesses excellentorganizational skills and the ability to workindependently•Ability to manage multiple projects andprioritiesStryker Biotech

Job Title: Sr. Clinical Research Associate Company: BioMarin Pharmaceutical Inc Location: Novato, CA Description: BioMarin Pharmaceutical Inc.At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.  Today, with three products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.  EEO/M/F/D/V To apply: Visit www.BMRN.com Job Code 10-0029 SUMMARY  Participates in the planning, oversees, and is accountable for the conduct of clinical studies, with a strong focus on enrollment, quality of data, site relationships, and oversight of challenging and/or complex studies.  RESPONSIBILITIES •           Regularly represents department in team meetings, leads teams and drive collaborative efforts (e.g., protocol development, CRO selection, etc.).•           Oversees and is accountable for feasibility assessments for new studies.•           Responsible for TMF contents and accountable for TMF reconciliation.•           Oversees and is accountable for the content of study documents (i.e., consents, study instructions, etc.).•           Oversees and is accountable for the content of study workshops and investigator meeting materials and presents at study training workshops and investigator meetings.•           Oversees and is accountable for the development and management of study start-up, maintenance, and close-out activities, including the development of the monitoring plan.•           Oversees and is accountable for the adherence to timelines, study quality, budget for assigned studies and participates in timeline development.•           Oversees and is accountable for the preparation of training materials and training of internal and external staff involved in the study team.•           Oversees and is accountable for the vendor identification and evaluation process including RFP development.•           Responsible for the assessment and management of vendor performance and in collaboration, develops and manages performance metrics.•           Oversees and is accountable for the consistency and quality of content of clinical protocols and amendments and leads the protocol development process.•           Assists in and is accountable for the development and completion of individual site recruitment and back-up plans and is responsible for the development of risk mitigation and contingency plans to keep trial enrollment on target.•           Accountable for the oversight of all monitoring of clinical sites, may include complex or challenging studies and sites.•           Oversees and is accountable for the identification and qualification of clinical investigators and assists in the selection of investigators.•           Oversees and is accountable for the development of investigator site budgets, manages routine site budget negotiations and assists with more complex site budget negotiations.•           Oversees and is accountable for the development of the Vendor evaluation and selection process and development of Vendor budget.•           Direct supervision of internal personnel including annual performance reviews and assists in the development of long-term professional development plans for direct reports.•           Thorough understanding of drug development.•           Other duties as assigned. EDUCATION Bachelor’s degree in biological science preferred. Combination of educational and work experience providing competencies to perform the required accountabilities specific to position.  EXPERIENCE •           4-6 years industry experience, including a minimum 4 years clinical research experience.•           Competent in the skills for the CRA II and the following:o          Experience in line management and/or mentoring of CR Assistants and CRAso          Contributes in process improvement teamso          Understanding of the clinical development plan and how the individual projects are impactedo          Demonstrates understanding of CRO and other vendor roles•           Ability to travel is required. To apply: Visit www.BMRN.com Job Code 10-0029

Job Title: Pre-Clinical Research Associate Company: Location: Stamford, CT Description: Clinical Research Associate II (Sr. CRA)A Successful Medical Device/Pharmaceutical Company is searching for an experienced Clinical Research Associate to lead pre-clinical trials of some exciting new products. The Pre-Clinical Research Associate is responsible for providing clinical and pre-clinical guidance, strategy, and support for the development of new technologies, new products, extended product claims, and pre-clinical foundation research. This may include the leadership of extended claims or other project teams; the development of pre-clinical strategies and study protocols; establishing and maintaining effective rapport with external physician advisors, pre-clinical investigators, and other applicable researchers; the identification and evaluation of pre-clinical investigators and sites; negotiation of contracts and budgets for pre-clinical studies; monitoring of pre-clinical work in progress; writing project status reports; assuring accurate record keeping and internal and investigational site compliance with applicable Federal Regulations, policies and procedures. - Strong knowledge of in vivo models and null hypothesis testing using applicable in vivo models - Effective written and verbal communication skills in the area of technical/clinical applications. - Strong command of medical and surgical terminology. - Demonstrated ability to persuasively influence external medical professionals and contract research organizations to ensure project deliverables are completed on time and within budget. - Ability to coordinate and lead multiple projects simultaneously. - Knowledge of FDA regulations concerning the conduct of pre-clinical and clinical studies. - Working knowledge of regulatory paths for Class II and III surgical devices - Strong working knowledge of the NRC Guide for the Care & Use of Laboratory Animals - Demonstrated knowledge of the laws and regulations pertaining to the use of animals in biomedical research - Knowledge and experience interacting with IACUC in both private CRO and academic institutional settings - Knowledge of international regulations for pre-clinical studies. Effective knowledge in searching medical literature and databases for clinical and technical information. - Extensive travel (25%) and on-site monitoring are to be expected. REQUIREMENTS: - A minimum of a Bachelors Degree in Life Science (Animal Science, Biology, Physiology) or, Biomedical Engineering. A Graduate degree with a demonstrated research experience is considered valuable. GLP-CP certification considered valuable.- Two (2) years experience in medical device/drug customer relations, pre-clinical research required. - Experience in Phase I clinical trials required. - Prior experience as a Study Director in a GLP pre-clinical research setting is considered valuable. - - Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Procedures (GMP) is preferred.

Job Title: Sr Clinical Research Associate Company: MedFocus Location: San Diego, CA Description: .ugDivBody_hj .ugFrame_hj .ugColWrap_hj .ugHeader_hj .ugHeadBot_hj .ugHeadBot_hj a:link .ugHeadBot_hj a:visited .ugHeadBot_hj a:hover, active .ugSeeLink_hj .ugLeftWrap_hj .ugLeftCol_hj .ugJobTitleLeft_hj .ugJobTitleLeft1_hj .ugLTable_hj .ugLHead_hj .ugLText_hj .ugMap_hj .ugMapplace_hj .ugRightWrap_hj .ugRightCol_hj .ugROver_hj .ugLeftLinks_hj a:link .ugBold_hj .ugRTitle1_hj .ugRtext_hj .ugFooter_hj .ugBanner_hj See all jobs at this company Job overview Company:  MedFocus Job Id:  Register to View Job Title:  Sr Clinical Research Associate Location:  San Diego, CA Job Category:  Pharmaceutical/Biotech Position Type:  Full-Time, Contract Education:  Bachelor of Science Experience:  5-10 Years Experience Company overview Since 1993, MedFocus has succeeded in meeting the contract staffing needs of our consultants and clients faster and more effectively than our competition through "specialized" recruiting exclusively in the pharmaceutical arena. By staying focused, MedFocus has become the firm of choice for both client companies and our consultant job seekers. MedFocus is headquartered in Chicago, IL and has offices in Philadelphia, PA and San Francisco, CA. Learn More about MedFocus Company Website About Us Sr Clinical Research Associate Job Description SR. CLINICAL RESEARCH ASSOCIATECOMPANY INFO:MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.Our client is a specialty pharmaceutical company focused on acquiring, developing and commercializing products for the prevention & treatment of gastrointestinal diseases and disorders and is seeking to add a Sr. Clinical Research Associate to their team in San Diego.RESPONSIBILITIES:• Assist in planning implementing, and managing clinical studies in accordance with FDA Regulations, Good Clinical Practices Guidelines (GCPs) and Company SOPs. • Support Clinical Research project teams and provide backup for other activities and projects.• Manage CRO activities in support of conduct of study(s)• Prepare monitoring plans as required.• Conduct clinical monitoring or Co-monitoring visits • Assist with in-house CRF clean-up for internal analyses • Participate in all aspects of clinical development and study management under the direction of the Sr. Manager, Clinical Research. • Provide support as required to the CTM. • Audit CRO study files• Assure accuracy of required clinical trial documents within Central Files (i.e., CVs, FDA 1572, Lab Certification and normal ranges, Financial Disclosure, etc.)• Interact with the CRO regarding the maintenance of project specific regulatory documents• Prepare and track investigational product (IP) supplies, packaging, and shipment requests and circulate these requests for appropriate approvals; • Work with the CRO, assist in securing necessary administrative (non-drug) supplies for clinical trials and process site requests for shipping supplies, as needed• Conduct frequent and timely review of CROs clinical trial monitoring schedule/monitoring reports/management tracking systems.• Assist in preparing, finalizing and maintaining operational documents (e.g., Meeting Minutes, Dashboard, Newsletters)• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations. QUALIFICATIONS:• 5-8 years experience as CRA• Computer proficiency, e.g. Microsoft Word, Excel, MS Project, PowerPoint, Access, ACT• Excellent interpersonal skills, effective communication, and team participation skills.• Willingness and ability to travel up to 20% of the time• BS/BA degree in Science-related field strongly preferred• At least 1 year as a Lead or Senior CRA preferred• Sites: in North America (Mexico, Peru, Guatemala). Some international travel will be required (20%).MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicablea

Job Title: Clinical Research Associate 2 Company: Covance Inc. Location: Columbia, SC Description: Covance - Job details ("")'>   Job details   Business TitleClinical Research Associate 2Requisition ID19786BRJob CategoryClinical ResearchLocationsColumbiaShift1Job PostingCOVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.About the Job• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties.• Ensure the integrity of the data submitted • Recruitment of potential investigators, preparation of EC submissions, negotiate study budgets, notifications to regulatory authorities, translation of study-related documentation.• Co-ordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact as assigned.About You• Ideally, a University or college degree (life science preferred)• Have typically at least 2 years experience as a clinical monitor• Willingness to travel between 50 – 80% of your time • A thorough knowledge of Good Clinical Practice (GCP) We OfferCovance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us!Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.Education/QualificationsRequired:•University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered•Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.•Thorough knowledge of monitoring procedures.•Basic understanding of the clinical trial process.Preferred:•Thorough knowledge of Covance S.O.P.s for site monitoring.ExperienceRequired:•Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).In lieu of the above requirements, candidates with three (3) years of site management and/or study co-ordinator experience will be considered.•Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.•Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.•Good planning, organization and problem solving abilities.•Ability to work with minimal supervision.•Good communication and interpersonal skills.•Good analytical and negotiation skills.•Computer competency.•Fluent in local office language and in English, both written and verbal.•Works efficiently and effectively in a matrix environmentPreferred:•One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. Index Monitor https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=20090&siteid=5090&AReq=19786BR&GQId=0 http://wrapguy.adicio.com/textjobs/jobs/covance_wkdiv/4792d3c50bea99fe0bf8b84da4e0b002.html

Job Title: Clinical Research Associate Company: MedFocus Pharm. Res.Opp. Location: Pleasanton, CA Description: CLINICAL RESEARCH ASSOCIATECOMPANY INFO:MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.Our client develops and commercializes highly sensitive diagnostic and blood screening tests and is seeking to add a Clinical Research Associate to their team in Pleasanton, California.RESPONSIBILITIES:•    Responsible for the design, planning, implementation and overall direction of clinical research projects; Coordinates the activities of relevant colleagues within Company and investigators to ensure compliance with the overall scientific study objectives. •    Maintains a high level of professional expertise through familiarity with scientific literature, product portfolio and competitive environment. Typically travels to field sites to monitor studies. •    This position requires an organized and detail-oriented individual with writing, analytical, technical and interpersonal skills to work with international investigators and key customers while representing Company in a professional manner.•    Planning and preparation of studies•    Designing and writing study protocols, reports and manuscripts•    Working with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites•    Collection and maintenance of legal and regulatory documentation, as applicable•    Managing training and coordinating certification of study site personnel•    Ensuring accurate and complete study management/data collection and transfer into the data management system•    Ensuring site compliance with regulations and study protocol•    Monitoring the sites and providing technical assistance, as necessary•    Managing material logistics for the studies•    Conducting reference material testing in-house•    Organization of investigators meetings, as necessary•    Participation in Project Team MeetingsQUALIFICATIONS:•    Bachelor’s or Masters in Biology, Chemistry, Molecular Biology or related discipline, Masters or PhD preferred•    3-5 years of CRA experience•    Extremely detail oriented•    Self starter with excellent lab skills•    Ability to work in a team situation•    Ability to solve problems in a detailed, comprehensive manner with demonstrated urgency and energy to handle problems•    Must meet timelines and mange sites•    Excellent written and verbal communication skills and good presentation skills are required•    MSWord, Excel, and PowerPoint sills are required.MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.