Clinical Research Associate Jobs

Job Title: Sr C&A Compliance Specialist Company: Energy Enterprise Solutions (EES) Location: Germantown, MD Description: Sr Certification & Accreditation Compliance Specialist Senior C&A Specialist (08-239/GSMEI) Germantown , MD Description Responsible for providing technical cyber security expertise as a senior member of a team supporting a large, diverse Federal client. This position will participate in daily security operations to help create, implement and maintain a comprehensive cyber security program in an operational environment. Functions to be supported include: Policy, Procedure and Standards Development; Certification & Accreditation of unclassified systems; Program, Project and System level Self Assessments; Strategic & Tactical Planning; Compliance Reviews; Technology Evaluations; Awareness and Training; and Vulnerability Management Regarding certification & accreditation, the Cyber Security Analyst builds and evaluates documentation for all phases of an unclassified C&A process including security categorizations according to FIPS 199 and NIST SP800-60, risk assessments according to 800-30, system security plans according to Program Cyber Security Plan, required 800-53 controls, control tailoring, and with particularly high focus on the following: system test and evaluation (ST&E) plans, 800-53A control assessment methods, evaluation of ST&E results, contingency plans and tests according to 800-34, security assessment reports, and POA&Ms. Interfaces with all management levels, system owners, administrative personnel, and highly technical cyber analysts. Candidates with a "Q" may be requested to implement these processes for classified systems. May assume the role of a certification agent to monitor and assess all phases of a C&A. Develops, writes and articulates reasoned judgments clearly and concisely of system descriptions, ST&E plans and ST&E results involving, for example, multiple firewall and IDS solutions. May function as a team lead/analyst of the ST&E team. The position may occasionally require sustained observations of technical testing during off-hours. Requirements A minimum of 10 years demonstrated experience in the Information Technology (IT), Information Assurance or Computer Security field, with specific experience implementing cyber security solutions in diverse operating environments. At least 8 years IT security or IT audit experience with demonstrated skills in technical writing, verbal communication, problem analysis and resolution; broad knowledge of IT security best practices including FISMA, FIPS, and NIST SP 800 series. Functional understanding of IT system components such as TCP/IP, network and host-based intrusion detection and prevention, vulnerability scanning, operating systems including Unix and Windows, routers, switches, and data base management systems including Oracle. Candidate must be able to obtain a DOE Q clearance. Desired Skills: Substantial experience performing detailed security assessment and testing, experience applying project management principles to systems security engineering efforts, and a B.S. degree in Computer Science, Information Systems, Engineering, or an equivalent discipline, and professional certification - CISSP, GIAC, IIA or CISA. About EES,LLC Energy Enterprise Soulutions, LLC. was established in September 2004 through the creation of a Small Business Administration (SBA) certified joint venture (JV) mentor-protege agreement between the majority owner 1 Source Consulting, Inc. and RS Information Systems . On December 5, 2005, EES was awarded a $1 billion dollar A-76 IT support contract by the U.S. Department of Energy over a 7-year period, one of the largest federal IT services contracts ever awarded to a small business. EES,LLC has grown to over 600 employees supporting federal clients in 10 states, providing a broad range of IT support. Our management team combines strong federal and industry experience, providing a deep understanding of industry best practices and its applicability to federal IT requirements. Today, EES, LLC supports a variety of program missions by applying business expertise and information technology to implement sound and affordable enterprise solutions. EES, LLC information technology professionals support management consulting, enterprise architecture and planning, cyber security, system development and engineering, centralized Web site services, seat management, information technology operations and infrastructure, and quality assurance and independent verification and validation services. Careers with Energy Enterprise Solutions, LLC (EES, LLC) feature excellent growth, very competitive health and welfare benefits and 401(k) program with a Company match. Please forward resumes to Register to View , To learn more, please visit our website: www.eesllc.net

Job Title: Clinical Research Associate Company: Location: Point Richmond, CA Description: Superior career opportunities for Sr. Clinical Research Associates and CRA II's  with our client who is a world leader in developing customized DNA-binding proteins for targeted gene regulation and genome engineering. Technology is being applied in diverse therapeutic areas including cardiovascular disease, diabetic neuropathy, neuropathic pain and HIV / AIDS.   Sr. CRA - COMPENSATION / BENEFITS / OTHER INFO.: Base salary: $90K to $100K (DOE) Position type: Full time / Exempt Work location: Point Richmond, CA Reports to: VP Clinical Affairs Citizenship / Residency Requirement: US Citizen or Permanent Residency status (Green Card). No H1B or H2B Visas Car: No Stock options: Yes Benefits: Yes Relocation assistance: Yes.   CRA II - COMPENSATION / BENEFITS / OTHER INFO.: Base salary: $72K to $78K+ (DOE) Position type: Full time / Exempt Work location: Point Richmond, CA Reports to: VP Clinical Affairs Candidate Citizenship / Residency Requirement: US Citizen or Permanent Residency Status (Green Card). No H1B or H2B Visas Car: No Stock options: Yes Benefits: Yes Relocation assistance: None. Local candidates only  Requirements SR. CRA - REQUIRED EDUCATION / EXPERIENCE / QUALIFICATIONS: BA/BS degree in a nursing, pharmacy, life sciences or health-related discipline 5 to 7 years of experience in planning and overseeing pharmaceutical clinical trials for a biotech company Demonstrated ability to independently supervise a clinical trial from initiation to close in accordance with regulations and with company policies and procedures Thorough knowledge of GCP, ICH and FDA regulations Ability to work on company site and to travel 30-40% Strong organizational skills, detail oriented, and able to multi-task and work effectively in a fast-paced environment Self-motivated, assertive and able to function independently or as part of a team Strong written and verbal communication; strong interpersonal skills Preference given to strong experience in pharmaceutical clinical trials. Device clinical trial experience does not qualify. CRO site monitoring experience alone does not qualify CRA III - REQUIRED EDUCATION / EXPERIENCE / QUALIFICATIONS: BA/BS degree in nursing, pharmacy, life sciences or health-related discipline 4 to 5 years of Pharmaceutical industry experience including direct site management Thorough knowledge of GCP, ICH and FDA regulations Strong experience in the initiation, management, and close-out of pharmaceutical clinical trials. Excellent organizational skills, detail oriented, and able to multi-task and work effectively in a fast-paced environment Self-motivated, assertive and able to function independently or as part of a team Strong written and verbal communication; strong interpersonal skills Ability to travel 30-40% Completion of a Profile Questionnaire is required. Technical telephone interview is required.   CRA II - REQUIRED EDUCATION / EXPERIENCE / QUALIFICATIONS: BA/BS degree in nursing, pharmacy, life sciences or health-related discipline 2-3 years of Pharmaceutical industry experience including direct site management of Pharmaceutical clinical trials for a biotech company Thorough knowledge of GCP, ICH and FDA regulations Excellent organizational skills, detail oriented, and able to multi-task and work effectively in a fast-paced environment Self-motivated, assertive and able to function independently or as part of a team Strong written and verbal communication; strong interpersonal skills Ability to travel 30-40% Completion of a Profile Questionnaire is required. Technical telephone interview is required. Preference given to strong experience in pharmaceutical clinical trials. Device clinical trial experience does not qualify. CRO site monitoring experience alone does not qualify. Experience as Clinical Trial Associate would have to match all requirements    If you meet the stated requirements, please email your resume in Word.doc format to [Click Here to Email Your Resumé] consideration. We regret that we cannot respond to candidates that do not meet qualifications

Job Title: Clinical Research Associate - CRA Company: ClinForce Location: San Francisco, CA Description: Experience/Minimum Requirements:  Minimum 2 years Field Monitoring experience with a CRO, Pharmaceutical or Biotech Company   Education/Degree:  BA/BS in a Life Science or related field Education/Degree:

Job Title: Clinical Research Associate Company: Not Listed Location: Baltimore, MD Description: Leading medical device company focused on spray cryotherapy for airway and pulmonary applications is currently seeking a Clinical Research Associate to initiate, run, monitor and closeout clinical trials and associated research studies. Join a fast-growing team of medical research professionals dedicated to providing new technologies for minimally invasive procedures that will benefit patient care. Responsibilities:  Initiate, manage, monitor and closeout clinical trials, in particular: Conduct clinical trials site initiation visits, including coordinating with clinical operations and principal investigator's team, training of PI and associated personnel; Monitor clinical trials for compliance study to protocol, regulatory and GCP requirements; Monitor data collection from sites and manage data correction or amendment process; Report to clinical trials project manager on clinical trial status, including enrollment and progress; Manage and report all AE and SAE occurrences with utmost integrity and responsibility; Participate in publication of clinical trials results, conference abstracts, posters, newsletters or other media, including preparation and interpretation of data with research team, or providing assistance to PI for publication purposes; Perform other duties as assigned. Additional Qualifications and Skills: ·        Abilityto maintain strict confidentiality; ·        Abilityto be involved in multiple trials at various stages simultaneously; ·        Abilityto communicate in an efficient and effective manner, both verbally, in presentation and in writing; ·        Extremelyself-motivated showing great professional initiative; ·        Avery proactive organizer; ·        Astrong desire to learn and try new things; ·        Strong,passionate understanding of and commitment to customer service; ·        Ableto work independently and with a team; ·        Proficientwith Microsoft Office Suite (Word, Excel, Outlook, Access, PowerPoint); ·        Knowledgeable of GCP, HIPAA, SOPs, clinical trials management; ·        Mustbe willing to travel (approximately 30-50%).   Requirements: Minimum four year degree from an accredited college in healthcare or life science field, preferably RN or other allied healthcare professional;Three to five years experience in managing sponsored trials for pharmaceutical, biotechnology or medical device company;Pulmonary/Respiratory experience preferred;Clinical research certification;Successful track record in running multiple trials;Experience with both medical and scientific communications;Demonstrated ability to work with multidisciplinary team. Location: Baltimore, MD Benefits:Broad and highly competitive employee benefit program, including: ·        Two weeks paid time off ·        Health Insurance with Rx ·        Employer funded Health Savings Account ·        Dental Insurance with orthodontic benefit ·        Vision Reimbursement ·        Life Insurance ·        Accident Insurance ·        Access to Group Long-term Disability Insurance ·        401(k) Retirement Plan with Employer Matching contribution ·        Prepaid financial planning decision support Supervisor:  ChiefScience Officer Send resumes to Register to View

Job Title: Regional CRA- Memphis, TN Company: MedFocus Location: Memphis, TN Description: REGIONAL CRA COMPANY 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 developing leading positions in seven major therapeutic areas and is seeking to add a Regional CRA to their team in Memphis , Tennessee . RESPONSIBILITIES: * Monitor multiple investigational sites within the oncology group in accordance with State and Federal Regulations, Good Clinical Practices and Standard Operating Procedures. * Work to ensure consistent implementation and successful completion of clinical research activities for assigned studies by conducting site initiation visits, routine monitoring visits, closeout visits and booster visits in accordance with the monitoring plan and Company SOPs. * Act as primary liaison between assigned sites and Regional Site Manager. * Communicate effectively with investigators and other research personnel, maintaining a professional demeanor. * Perform source document verification of CRFs according to SOPs and study specific requirements. * Ensure Case Report Forms (CRFs) are complete, legible and accurately reflect the source data. * Ensure appropriate reporting of adverse events by investigators according to GCP and SOPs. * Train on-site team, including the investigator and other site personnel, in proper conduct of clinical studies. * Monitor SAE reporting and request primary and follow-up information according to SOP. * Review protocol violations with the investigator and take corrective actions to ensure future compliance. * Responsible for the reconciliation of drug accountability records at sites. * Responsible for the reconciliation of all regulatory documents at sites. * Provide timely monitoring reports in accordance with SOPs. * Participate in clinical study team meetings. * Assist Data Management in the resolution of data queries. * Ensure availability of all study supplies at sites and participate in other tasks as needed. QUALIFICATIONS: * Minimum of two years experience monitoring clinical studies in the oncology therapeutic area. * Good understanding of the clinical development process, GCPs/ ICH/CFR regulations. * Knowledge of RECIST criteria; various oncology therapeutic area expertise, differing by study/tumor type. * Ability to utilize various electronic systems - intermediate computer skills required. * Ability to work independently. * Effective communication (verbal and written) and organizational skills. * Excellent interpersonal skills. * Excellent organizational and time management skills * Self-motivated, detail-oriented, and flexible * Commitment to teamwork. * Must have own laptop. * Ability and willingness to travel approximately 50-60%. EDUCATION: * BA, BS in a relevant scientific discipline required. * CCRA Certified preferred. 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.

Job Title: Lead Clinical Research Associate w/Oncology Experience-Contract Company: Kelly Scientific Resources Location: Exton, PA Description: We have an excellent opportunity at Kelly Clinical Research for a Clinical Operations Lead/Sr. CRA to provide oversight and support to the clinical operations team of a biopharmaceutical company focused on the discovery and development for treatments of cancer, inflammatory and infectious diseases. The COL will be involved in planning, conduct, and closeout of assigned oncology clinical studies, therefore oncology experience is a must. Will also be rsponsible for vendor relations, IRB's and SAE's. This is an in-house, contract position based in Exton, PA but does require less than 25% travel to sites and vendors based on study demands. Job duties include: Provide sponsor oversight of clinical monitoring activities including site initiation and management, document management, study training, safety reporting, and oversight of regional leads and field CRAs including management of trip report review and issue resolution. Manage country and site feasibility, selection and activation, essential document collection, clinical supply tracking, negotiation of site contracts and budgets, and supports director in managing overall study budget. Provide oversight to CROs, central imaging vendors and labs, and other study vendors as needed. Coordinate the development and review of clinical study documents including informed consent forms, site budgets, study manuals, and operational plans. Coordinate meetings with study team members, vendors, and site staff. Assist global study director with additional study management activities as needed. To qualify for this opportunity, applicants must have the following: Bachelors in allied health preferred; will consider an Associate's in allied health with appropriate experience (eg RN, MT) Minimum of 5 years In-house CRA experience with at least 2 years in a lead role Working knowledge of GCP/ICH regulatory guidelines and data management practices Proficiency with document management practices relative to assuring quality of essential documents and other study-related documents Working knowledge of international regulatory practices and timelines for study initiation in various regions Demonstrated experience of managing global studies and vendor management Working knowledge of EDC/eCRFs Candidates must be able to work a flexible schedule to accommodate interactions with team members and sites globally. Must have strong attention to detail and good organizational, problem-solving, and leadership skills. Also must have solid oral and written communication skills with the ability to communicate effectively and professionally with various clinical trial and site personnel. To receive immediate consideration for this opportunity, please Apply Now and submit a current version of your resume. Candidates must be eligible to work for any employer in the U.S. without restriction. Corp-to-corp candidates need not apply. Kelly Scientific Resources Clinical Research is a part of Kelly Scientific Resources, the largest and fastest-growing scientific/clinical research staffing company in the world, employing more than 5,000 people globally. Established in 1995, Kelly Scientific Resources is a business unit of Kelly Services, the first and most respected name in staffing. We provide contract, temp-to-perm and direct hire staffing solutions to the world's most well-respected companies. Disciplines we service include clinical research associates, data management, regulatory affairs, biostatistics and analysis, medical writing, project management, and clinical operations and support. Kelly Services is an Equal Opportunity Employer Job Requirements Please refer to the job description above.

Job Title: EHS Compliance Specialist - Company: Location: hattiesburg, MS Description: An international manufacturing company is seeking an EHS manager for its plant in south central Mississippi. The position requires a bachelor?s degree in environmental science, engineering, geosciences or a related area and a minimum five years experience with environmental regulatory compliance preferably in an industrial facility or in consulting. Experience with environmental compliance at a forest products facility is a plus. Duties will include: assistance in preparation of air and wastewater permits, data collection and analysis, report preparation, sample collection and other fieldwork and related tasks. This position offers an excellent salary and benefits. Interested applicants are invited to send resumes (MS Word format only) to Register to View Please reference P3 Job #1029-MS when applying. EEO/AA Location: South Central Mississippi Compensation: Excellent salary and benefits Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests.

Job Title: CRA II Company: Location: Fremont, CA Description: Superior career opportunity for a Clinical Research Associate (CRA) with a premier  medical device company in Fremont CA. Organization is expanding and seeks top grade CRA’s that want to expand their professional growth with a visionary organization that offers challenging and meaningful work, a great work environment and opportunities for advancement.   COMPENSATION/BENEFITS / INFO. :  Salary: Negotiable and highly competitive. Please inquire Benefits - Full Bonus incentives: None Relocation Assistance: none. Local candidates only Interview Travel Reimbursed - Yes Position type: Full-time Work location: Fremont, California   CORE JOB FUNCTIONS: Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40-50% travel) for GCP compliance according to Company SOP Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites Prepare project management reports for clients, project personnel, and management Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries Resolve queries of CRF data with study site personnel Review Tables and Listings generated from study data Assist in writing Clinical Study Reports Requirements REQUIRED Education / Experience / Qualifications: BS/BA preferred but not required Minimum of 2 years of work experience in clinical research, data management, regulatory affairs, or other relevant healthcare research position Experience with a biotechnology company Excellent organizational skills and ability to manage time and work independently  Ability and willingness to travel in U.S. mainland and Hawaii Local candidates   If you are interested and meet the required qualifications, please email your resume in Word.doc format to [Click Here to Email Your Resumé]   We regret that we cannot respond to candidates that do not meet stated requirements.

Job Title: Regional Clinical Research Associate Company: Aerotek Scientific Location: North Kansas City, MO Description: One of Aerotek's largest clients, a well respected Pharmaceutical Company has an immediate need for 1 Contract, Regional Home-Based Clinical Research Associates in Missouri/Kansas. (KC, Johnson County, Jackson County, etc.) NO traveling - all local sites. Major job duties and responsibilities:- Home-Based, Regional Travel.- Responsible for monitoring ~10-11 clinical trial sites.- Responsible for training sites on protocol and other study related issues.- Perform Pre-Study to Closeout Visits of Clinical Sites.- Liaise with sites and in-house team.- Complete trip reports in a timely manner.Job requirements and qualifications:- Must have at least 2-3 Years of Home-Based CRA Experience.- Experience in the Pharma, Medical Device, Biotech or CRO industry.- BA/BS or RN preferred.Mobile phone, Scanner, Fax Machine, etc. will be supplied. This is a one year CONTRACT that starts January 1st. Can be renewed next January (2010). Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers. CompetenciesDesired:Clinical Research, Monitoring, FDA, Regional Home Based, CONTRACT Contact Information Contact: Gorr,Grant A. --> Email this job Email: Send Email Now Address: US-MO-North Kansas City Phone: Register to View Fax: Register to View Reference Code: 1822549 Click here to see all

Job Title: Manager/Sr. CRA Company: Location: Bridgewater, NJ Description: ImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Our efforts have resulted in a commercially available novel therapy, ERBITUX® (cetuximab), as well as a broad spectrum of innovative product candidates with potential application in multiple tumor types. As a member of the oncology community, we are committed to providing treatments to meet the unmet needs of cancer patients. To fulfill this commitment, ImClone Systems fosters integration of the principles of teamwork and scientific integrity into all facets of the Company's activities. We believe that these values will benefit patients, physicians, and our employees while creating value for our shareholders. GENERAL SUMMARY Under minimal supervision, manages the conduct of one or more clinical oncology investigations. Performs assigned responsibilities to ensure timely completion of departmental goals and objectives. Prepares and reviews management reports, ad hoc reports, summaries, analyses on clinical databases. Coordinates and participates in co-monitoring of these investigations. Assists with special projects as assigned. ESSENTIAL DUTIES AND RESPONSIBILITIES 1. Manages the conduct of assigned clinical investigations and activities associated with it. 2. Manages the interaction of appropriate departments and staff to support and maintain the clinical investigations. 3. Assists with the management of the co-monitoring of assigned clinical investigations and coordinates/participates in the co-monitoring of assigned clinical investigations as needed. 4. Oversees the Quality Control review of clinical trial patient databases and clinical files. 5. Supervises training programs to assure consistency and compliance in monitoring of clinical investigations. 6. Prepares and distributes monthly management reports, ad hoc reports, summaries, or analyses as required. Prepares status reports for assigned clinical investigations. 7. Prepares drug usage projections and tracking for assigned clinical investigations as requested. 8. Participates in the periodic review and revision of departmental policies and SOP’s to assure compliance with corporate policies, good clinical practice procedures (GCP’s), or regulations of governmental agencies. 9. Contributes to the selection process of new hires, including reviewing candidates credentials, interviewing candidates, and making hiring recommendations. 10. May assist with preparation and execution of Investigator meetings. 11. Assists with preparation of department budgets, timelines, and project plans. 12. Maintains professional skills by keeping abreast of literature, attending conferences, courses and meetings. 13. Maintains knowledge of U.S. and foreign regulations, guidelines, policies and practices for conducting clinical investigations. 14. Follows departmental policies, procedures and SOP’s. 15. Trains, develops and supervises clinical staff. 16. Negotiates contracts and budget for assigned clinical investigations. 17. Develops and reviews study protocols and CRF’s. 18. Participates in internal/external audits. 19. Reviews and participates in finalizing and obtaining approval of final study reports. 20. Participates in dissemination of clinical information to the clinical team members, as appropriate. 21. May serve on cross teams for evaluation of new clinical research strategies. ESSENTIAL KNOWLEDGE, SKILLS AND EXPERIENCE 1. A minimum academic degree in Nursing (R.N. or B.S.N.), Life Sciences (B.A. or B.S.), Pharmacy or Medicine. Experience requirements may be less with advanced degrees. 2. An advanced degree (M.S. or PharmD) is preferred. 3. 5-10 years experience of progressively increasing clinical research experience within the pharmaceutical industry, global experience a plus. 4. Experience in drug development, especially FDA regulations and GCP’s or Associates of Clinical Pharmacology CRA certification. 5. Experience in IND/NDA/BLA submissions. 6. Global experience or management of CRO’s a plus. 7. Ability to resolve and make judgements regarding administrative, scientific, and/or clinical problems with minimal supervision. 8. Ability to deliver oral presentations and write in a clear, focused, and concise manner. Requirements Please refer to the Job Description for the qualifications.