Coordinator Clinical Research, (Non-RN)

at  Eastern Virginia Medical School

Overview:
The primary responsibility of the Clinical Research Coordinator is to manage all aspects of conducting clinical trials. The Clinical Research Coordinator is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, the Clinical Research Coordinator will act as liaison between the investigators, primary care providers, the institutional review board (IRB), and the sponsor. Along with the investigator, the Clinical Research Coordinator will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the Clinical Research Coordinator is responsible for all data and source documentation, adverse experience reporting, and maintenance of complete regulatory files.

Responsibilities:

• Review the protocol, informed consent form, and follow-up procedures with potential study subjects. Ensure the subject understands the study prior to signing the consent form. Ensure the current approved informed consent is signed before subjects are screened and enrolled and ensure adherence to protocol requirements.
• Subject recruitment and ongoing communications with primary care physicians and study staff. Maintain telephone contact with subjects in between visits, as needed.
• Review and verify all relevant source documentation in the subject’s medical record to confirm study eligibility.
• Evaluating studies with a keen insight as to the study population readily available for recruitment. Running detailed EHR reports to identify potential patients. Once a subject pool is identified, determining whether the study budget is adequate to pursue the trial.
• Maintain source documentation for all CRF entries, including clinic chart visit notes, lab data, and procedure reports. Provide auditors with completed CRFs, medical records, lab data and other source documents for review.
• Administer study drug therapy as needed and maintain the study drug dispensing logs. Assess and document subject compliance with medications and visits.
• Review laboratory data and communicate abnormal values to the primary care provider and investigator. Assess subject response to therapy and evaluate for adverse events.
• Ensure appropriate specimen collection (experience with phlebotomy and processing/shipping of specimens highly desired).
• Submit all study materials, amendments, continuing review reports and adverse events to the appropriate IRB for approval and documentation.
• Review with the principal investigator and other study staff the inclusion/exclusion criteria, overall structure, and requirements of each protocol.
• Attend and participate in weekly clinical research meetings, weekly general research meetings and weekly educational programs. Attend study-related meetings as appropriate.
• Budget and contract negotiations with sponsors.

Qualifications:
Candidate should be able to develop and maintain effective relationships with public, partners, customers, and co-workers; while working cooperatively and effectively with others to achieve common goals. Ability to manage time and resources to ensure assignments are completed accurately and deadlines are met. Meets attendance/punctuality requirements. Ability to adapt to changing work environments, work priorities, and organizational needs. Take independent action to address and resolve problems. Ability to expresses ideas effectively and demonstrate sound judgment with regard to decision-making. Ability to deal with others in a direct honest manner and comply with all ODU policies and procedure.

Prior Experience in clinical practice or research experience. Previous experience with clinical research protocols required. Customer service-oriented individual is required.

• Advanced medical degree (MD, RN, PA, NP) is a strong plus in a candidate

Location : Location: US-VA-Norfol

• Review the protocol, informed consent form, and follow-up procedures with potential study subjects. Ensure the subject understands the study prior to signing the consent form. Ensure the current approved informed consent is signed before subjects are screened and enrolled and ensure adherence to protocol requirements.
• Subject recruitment and ongoing communications with primary care physicians and study staff. Maintain telephone contact with subjects in between visits, as needed.
• Review and verify all relevant source documentation in the subject’s medical record to confirm study eligibility.
• Evaluating studies with a keen insight as to the study population readily available for recruitment. Running detailed EHR reports to identify potential patients. Once a subject pool is identified, determining whether the study budget is adequate to pursue the trial.
• Maintain source documentation for all CRF entries, including clinic chart visit notes, lab data, and procedure reports. Provide auditors with completed CRFs, medical records, lab data and other source documents for review.
• Administer study drug therapy as needed and maintain the study drug dispensing logs. Assess and document subject compliance with medications and visits.
• Review laboratory data and communicate abnormal values to the primary care provider and investigator. Assess subject response to therapy and evaluate for adverse events.
• Ensure appropriate specimen collection (experience with phlebotomy and processing/shipping of specimens highly desired).
• Submit all study materials, amendments, continuing review reports and adverse events to the appropriate IRB for approval and documentation.
• Review with the principal investigator and other study staff the inclusion/exclusion criteria, overall structure, and requirements of each protocol.
• Attend and participate in weekly clinical research meetings, weekly general research meetings and weekly educational programs. Attend study-related meetings as appropriate.
• Budget and contract negotiations with sponsors