Clinical Research Associate Jobs

Job Title: Clinical Research Associate Company: BakerIT Location: Minneapolis, MN Description: Performs the following tasks with supervision: 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 Investigational Plan, study budget and project schedule, study training materials, and study reports in consultation with the Clinical Trial Leader and cross-functional project team, and investigators. Assists Clinical Trial Leader 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 initiatives. May conduct electrical strip and/or episode review as needed. May review center activation documentation prior to CTL approval. Requirements: BASIC QUALIFICATIONS: EDUCATIONJOB EXPERIENCE *Bachelor's degree in engineering, biological sciences or related medical/scientific field KNOWLEDGESKILLS/COMPETENCIES *Knowledge of clinical research study processes and study design; ability to incorporate and adhere to Good Clinical Practices and regulatory standards DESIRED/PREFERRED QUALIFICATIONS: EDUCATION & JOB EXPERIENCE *Some experience supporting clinical research or similar experience in a medical/scientific area *Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates) preferred KNOWLEDGE & SKILLS/COMPETENCIES *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.

Job Title: IN-HOUSE CRA Company: MedFocus Location: Minneapolis, MN Description: IN-HOUSE CRA COMPANY INFO: NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a In-house CRA to work in Minneapolis, MN. Our client makes it possible for millions of people to resume everyday activities, return to work, and live better, longer. RESPONSIBILITIES: The 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). Performs the following tasks with supervision: 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 Investigational Plan, study budget and project schedule, study training materials, and study reports in consultation with the Clinical Trial Leader and cross-functional project team, and investigators. Assists Clinical Trial Leader 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 initiatives. May conduct electrical strip and/or episode review as needed. May review center activation documentation prior to CTL approval. 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 Good Clinical Practices and regulatory standards Some experience supporting clinical research or similar experience in a medical/scientific area Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates) 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. KEYWORDS: Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH & GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor 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. PUT YOUR INTEREST INTO ACTION AND CLICK APPLY NOW!!!!

Job Title: Senior In-House CRA Company: MedFocus Pharm. Res.Opp. Location: Seattle, WA Description: SENIOR IN-HOUSE CRA COMPANY INFO: NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Senior In-House CRA to work in Seattle, WA. Our client is committed to being a biopharmaceutical-industry leader with a diversified portfolio of proprietary oncology drugs. RESPONSIBILITIES: This position is part of the clinical monitoring function of international/global clinical trials This position would work both directly and with contracted organizations (e.g. CROs) and focuses on coordination of all activities required to initiate, monitor and complete clinical programs. In addition, this person will oversee and act as the mentor for less senior members of the Clinical Trial Team and may manage direct reports. The Sr. CRA will coordinate and manage vendor processes for the clinical monitoring function of clinical projects, including monitoring, and central laboratories. Will participate in preparation of clinical documents such as protocols, case report forms and informed consent forms. Facilitate the flow of information between contract CRAs, CROs and in-house team members and other involved members of the department and CTI. Participate in the design of clinical studies in collaboration with senior management, medical monitor, biostatistician, and regulatory affairs. May monitor clinical studies for protocol compliance and ICH/GCP adherence (expected to be assigned at least 1 site for monitoring). QUALIFICATIONS: Requires 5+ years Clinical Monitoring experience or equivalent. Experience in the Pharmaceutical industry is highly preferred. Bachelor's degree in scientific discipline, RN or health care professional or equivalent. An advanced degree is a plus. Experience managing CRO relationships desired. Oncology and Hematology Clinical Research experience preferred. Ability and willingness to travel is required (domestic and international). Must have a strong understanding of clinical drug development process and thorough knowledge of FDA and ICH requirements. KEYWORDS: Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH & GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor 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. PUT YOUR INTEREST INTO ACTION AND CLICK APPLY NOW!!!!

Job Title: ONCOLOGY REGIONAL CRA Company: MedFocus Pharm. Res.Opp. Location: Los Angeles, CA Description: ONCOLOGY REGIONAL CRA COMPANY INFO: NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Oncology Regional CRA to work in West Coast. Our Client is a global Clinical Research Organization providing services through all phases of clinical development. RESPONSIBILITIES: Major responsibility is to Co Monitor to help with sites. Ensure timely collection of all clinical study documents Routine monitoring of source documents and previous site visit issue resolution Comparison of regulatory documents between electronic file and site regulatory files for compliance issues Conduct site qualification, initiation, monitoring and close-out visits of moderate to complex clinical studies according to regulatory standards, SOPs and contract requirements Ensure compliance with protocol and overall clinical objectives Monitor investigator study files for compliance and accuracy Verify clinical trial material/investigational product accountability and compliance Identify and implement ways to improve site performance (e.g., increase enrollment rate or improve case report form completion) Report the status of clinical studies to the Project Lead as required Write, proofread and/or edit documents related to clinical research, including but not limited to clinical monitoring plans, project lead reports, monitoring visit reports, case report forms, telephone contact reports, sponsor and investigator correspondence, notes to study files, meeting agendas and meeting minutes QUALIFICATIONS: BS or RN degree 5+ years experience monitoring 2+ years of recent Oncology Monitoring. Solid Tumor is a plus. Ability to travel a minimum of 80-90%; with overnight stays. Knowledge of US federal regulations, ICH Guidelines and GCP Committed to quality and excellence Excellent organizational skills Strong communication skills (verbal/written/presentation) Computer proficiency, including use of standard software (word processing, spreadsheet, graphics, databases and e-mail) Time management skills and problem solving abilities KEYWORDS: Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH & GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor 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. PUT YOUR INTEREST INTO ACTION AND CLICK APPLY NOW!!!!

Job Title: CRA III Company: MedFocus Pharm. Res.Opp. Location: Scotch Plains, NJ Description: CRA III COMPANY INFO: NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a CRA III to work in Scotch Plains, NJ. Our client embraces research and science - bringing innovative ideas, products and services to advance the health and well-being of people. RESPONSIBILITIES: Responsible for IDE site management and clinical monitoring in accordance with contractual agreements, department guidelines, work instructions, applicable federal and state regulations, ICH guidelines. Travel approximately 50-60%. Periodic travel to sponsor headquarters for up to 1 week at a time required. Efficiently manage between 6-8 study sites. Monitoring activities to include review of: device accountability records regulatory records subject eCRFs and source documentation subject enrollment records engage CRC and PI concerning visit findings and action plans. Prepare pre- and post-monitoring visit correspondence with good attention detail and high level of quality. Active engagement and collaboration with study sites to ensure compliance with sponsor as well as IRB reporting requirements. Active engagement and collaboration with study sites to resolve queries and open action items in a timely manner. Proactive identification and management of potential quality concerns. Training of new study site personnel on protocol and study requirements. Provide real-time updates to Project Manager and sponsor Project Team. Position may be remote/home-based depending on applicant's location and needs of the study. QUALIFICATIONS: Ability to work independently with minimal oversight if remotely based. BA/BS in nursing and/or life or health sciences. A minimum of 5 years experience in clinical research; 3+ years as a clinical site monitor. Experience with device trials strongly preferred. Sound working knowledge of the Code of Federal Regulations, Good Clinical Practice and ICH guidelines as applied to drug trials. Ability to establish and maintain effective working relationships with study site personnel other team members. Ability to communicate in a professional but results-driven manner with both site coordinators as well as surgeons. Sound knowledge of medical terminology, particularly spine and related pathologies. Able to review and interpret patient medical records and draw concise conclusions. KEYWORDS: Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH & GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor 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. PUT YOUR INTEREST INTO ACTION AND CLICK APPLY NOW!!!!

Job Title: CRA or Sr CRA - Regional - CNS, Psych or Oncology Experience Company: Worldwide Clinical Trials Location: San Francisco, CA Description: Worldwide Clinical Trials (WCT) is a leading therapeutically focused Contract Research Organization (CRO) that applies deep therapeutic expertise to help customers achieve their drug development goals. WCT's global footprint, full complement of development service offerings, and innovative use of proprietary and cutting edge technology, bring about an environment which allows us to focus on identifying optimal opportunities for successful product development. We develop sophisticated and innovative approaches to research, with primary focus in the areas of cardiovascular and central nervous system medicine, along with significant experience in Chronic Inflammatory Disease, Metabolic / Endocrinology and Oncology. Our total focus is on exceeding customer expectations. Our ability to meet this objective is based upon our employees sharing a common goal with our customers. Namely, to act as the customer would if they were conducting the project themselves. We are currently seeking highly experienced individuals to join us in the position of Clinical Research Associate and Senior Clinical Research Associate. The positionis located regional home-based. POSITION SUMMARY: Identify potential investigators for studies to be initiated; Participate in pre-study and study initiation visits; Ensure completeness and compile regulatory documents (e.g. IRB approval, informed consent, lab certification etc.); Coordinate study material (e.g. CRFs Clinical Trial Material ) shipment and receipt by study site; Assess protocol adherence at study site; Ensure proper storage of CTM and documentation of CTM accountability; Check CRFs for accuracy and completeness; Verify adequate source documentation; Transmit CRFs to appropriate person/persons, Frequent and complete communications with sponsoring company and study sites; Maintain documentation of telephone communications; Generate written correspondence with study sites; Prepare reports of monitoring visits; Complete CRF review, retrieve CRFs and transmit to appropriate person/persons; Resolve data management queries; Ensure compliance with regulatory requirements for CTM accountability; Ensure compliance with regulatory requirements for study files; Complete final study termination visit report; and all other duties associated with clinical monitoring. OTHER SKILLS AND ABILITIES: Working knowledge of FDA regulations, ICH Guidelines and HIPAA; Understanding of corresponding standard operating procedures; Ability to understand and coordinate multiple study protocols; Oral and written communication skills; Planning and organizational skills; Understanding of clinical research principles and process; Data collection and editing skills. REQUIREMENTS: Bachelor's degree in the life sciences or healthcare discipline. Minimum 5 years experience within clinical research, minimum 3 years experience as a CRA Thorough knowledge and understanding of ICH GCP and FDA regulations Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint Good oral and written communication skills with the ability to lead meetings Experience working in a team environment under time and resource pressures Ability to travel as needed. Within WCT, we offer an excellent salary and employee benefit package to include, but not limited to, medical, dental, vision, flexible spending account, company paid life insurance, voluntary life insurance, short & long term disability, company matching 401K, and comprehensive paid time off. If you have the experience required, and feel you are the dynamic person that we are looking for, please send your resume in a Word document via email to: Register to View

Job Title: REGIONAL CRA Company: MedFocus Location: Princeton, NJ Description: REGIONAL CRA - PRINCETON, NJ COMPANY INFO: NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Regional CRA to work in Princeton, NJ. Our client is dedicated to offering products and services in other therapeutic areas where we can make a difference. RESPONSIBILITIES: Assist with: Execution of the detailed site feasibility process with sites; Tracking of feasibility data to provide site list to Project Managers and Clinicians for consideration for the trial; Communication of the finding to the Project Manager. Prepare and coordinate the trial set-up and maintenance, appropriate training materials and guidelines, and other project-related and/or department-related duties. Coordinate the logistics of the study start-up processes e.g. Archive file setup, initial shipping of blank Case Record Forms (CRFs) and Investigator Trial Files and other trial supplies. May reviews all drafts and final CRF prototypes for content, consistency and SOP criteria and coordinates printing. Prepare and distribute regulatory documents and other associated study-startup activities. Update and manage site information in appropriate database. Track all trial-related documents, including but not limited to Confidentiality Agreements (CDAs), contracts, regulatory documents. Provide status reports to their Manager and/or Project Manager on a weekly basis. Receive and review all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference, and forwards documentation to Archives, as required. Review amended regulatory documents accordingly. Ensure that regulatory documents are updated in a timely and appropriate manner. Provides quality overview and consistency checks on informed consent forms (ICFs) Coordinates printing and dissemination of the final CRF prototype to investigator sites, in-house, and regional staff after final approval by the core project team. Assist with the Project Manager in the design, ordering, shipping, tracking, and return of drug, ancillary, and other clinical supplies as well as managing inventory of all supplies and electronic/paper data collection tools. Maintain Trial Master File (TMF) ensuring study documents are filed in accordance with NN SOPs. Performs ongoing reviews, at the direction of the Project Manager, and ensures completeness of the TMF in Archives for compliance to Good Clinical Practice (GCPs) and SOPs as directed by the Project Manager. Provide updates of study status to Project Manager on a regular basis with trial metrics. Attends Clinical Trial Unit (CTU), as requested by the Project Manager. Ensures adequate dissemination of information; is central to the information network through communication with investigational sites, in-house, and regional staff. Distribute protocol amendments to study sites and ensure approval. May liaise with Institute Review Boards and study site staff for submissions and approvals. May be responsible for tracking of such. Coordinate internal receipt and routing of all Serious Adverse Event (SAE) reports to the Project Manager, Clinicians, Clinical Research Associates (CRAs), and Product Safety & Surveillance. Reviews SAE reports for accuracy and completeness and communicates any discrepancies and/or questions to the investigational sites and/or CRAs for resolution. Distribute Investigational New Drug (IND) safety letters to sites and ensure approval. Confirm IRB notification. Responsible for tracking IND safety letters. 2-5 Experience BS Degree Willingness to travel 80-100% (~ 4-5 days each week) including overnight stays KEYWORDS: Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH & GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor 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. PUT YOUR INTEREST INTO ACTION AND CLICK APPLY NOW!!!!

Job Title: Senior CRA (PERM) Company: Yoh Location: Rolling Meadows, IL Description: Yoh has a direct hire opportunity for a Senior CRA to join our client located in Rolling Meadows, IL. Job Responsibilities: Independently responsible for all activities of the clinical trial including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation. Devise and write study protocols, investigator manuals, site specific instruction manuals and design case report forms for new and modified products. Prepare clinical reports and clinical / non-clinical sections of regulatory submissions and prepare scientific abstracts, posters and publications arising from the trials. Assist with the management of key study parameters (i.e. start-up activities, drug preparation, enrollment, data collection, etc.) Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem. Maintain a high level of familiarity with clinical literature in field of study and related areas and stay up to date on major advances in infectious disease diagnosis and cancer detection and the use of new tests and advances in clinical practice.Required Skills: Bachelor's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent. Minimum of 5+ years experience with In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, either in infectious disease and/or cancer diagnostics. Previous hands-on experience in clinical research at either a pharmaceutical/biotech company or hospital is highly desirable. Excellent knowledge of good clinical trial design, including the number and types of subjects and specimens that will be required, the conditions under which specimens must be collected, potential interferants for a given disease, and the current gold standard for the diagnosis of that disease. Requires experience in monitoring sites and excellent team skills. Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials. Must also know who the thought leaders are for a given disease condition and the institutions with access to the required study populations. Knowledge of GCP & ICH guidelines and FDA regulations. This is an in-house base position with 30-50% travel required Discover all that's possible with Yoh. Apply now. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

Job Title: Clinical Research Specialist 1 - 26205 Company: ConsignMed Location: Mounds View, MN Description: The CRA will work closely with the CTL to satisfy applicable clinical and regulatory requirements and Medtronic internal requirements for clinical studies. Focuses on assigned areas of clinical study management, and/or coordinates and conducts site monitoring (and oversight of CROs). MAIN JOB DUTIES/RESPONSIBILITIES Performs the following tasks with supervision: 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 Investigational Plan, study budget and project schedule, study training materials, and study reports in consultation with the Clinical Trial Leader and cross-functional project team, and investigators. Assists Clinical Trial Leader 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 initiatives. May conduct electrical strip and/or episode review as needed. May review center activation documentation prior to CTL approval. BASIC QUALIFICATIONS: EDUCATION & JOB EXPERIENCE *Bachelor's degree in engineering, biological sciences or related medical/scientific field KNOWLEDGE & SKILLS/COMPETENCIES *Knowledge of clinical research study processes and study design; ability to incorporate and adhere to Good Clinical Practices and regulatory standards DESIRED/PREFERRED QUALIFICATIONS: EDUCATION & JOB EXPERIENCE *Some experience supporting clinical research or similar experience in a medical/scientific area *Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates) preferred KNOWLEDGE & SKILLS/COMPETENCIES *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.

Job Title: REGIONAL CRA Company: MedFocus Location: Morrisville, NC Description: REGIONAL CRA COMPANY INFO: NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Regional CRA to work in Morrisville, NC. Our client is a global leader in pharmaceutical services, improving healthcare worldwide by providing innovative, quality professional expertise, market intelligence and partnering solutions to meet the dynamic needs of the pharmaceutical, biotechnology and healthcare industries. RESPONSIBILITIES: Looking for experienced a Clinical Research Associate who will work regionally from home and be responsible for monitoring the progress of clinical trials at investigative sites, to ensure that they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures, ICH-GCP, and all applicable regulatory requirements. This person will be completely accountable for the site management and data quality of each site for which they are responsible. They must be able to operate a home-based office and be fully functional as a home-based monitor. Travel will be upwards of 70%-80%. Minimum of 2 years as a regional CRA/Monitor. Resume must outline/explain relevant monitoring experience/skills. Strong attention to detail and Medical Terminology required. Ability to effectively communicate and complete accurate reports/forms, etc. 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. KEYWORDS: Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH & GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor 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. PUT YOUR INTEREST INTO ACTION AND CLICK APPLY NOW!!!!