Clinical Research Coordinator - Non RN

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

• Possess a sound and in-depth understanding of each study protocol that has been assigned as a primary responsibility.

• Complete and pass the required courses/tests/certificates and human subjects/ethics training courses.

• Serve as the main point of contact with responsible parties.

• Review with the principal investigator and other study staff the inclusion/exclusion criteria, overall structure, and requirements of each protocol.

• Submit all study materials to the appropriate IRB for approval.

• Develop and distribute study materials as needed

• Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and study staff, as appropriate.

• Submit amendments, continuing review reports and adverse events to the IRB.

• Facilitate budget/contract negotiations and prepare and submit Office of Research Checklists and Financial Disclosures

• Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility.

• 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.

• Ensure that the randomization procedure is followed as per protocol guidelines.

• Document protocol exemptions and deviations, as appropriate.

• Ensure adherence to protocol requirements.

• Schedule subjects for follow-up visits.

• Maintain telephone contact with subjects in between visits, as needed.

• Assess subject response to therapy and evaluate for adverse events.

• Review laboratory data and communicate abnormal values to the primary care provider and investigator.

• Assess and document subject compliance with medications and visits.

• Administer study drug therapy as needed and maintain the study drug dispensing logs.

• Ensure appropriate specimen collection. Experience with phlebotomy and processing/shipping of specimens highly desired.

• Ensure appropriate specimen collection.

• Attend study-related meetings as appropriate.

• Communicate regularly with the principal investigator about study-related issues.

• Coordinate the activities of various research team members to ensure completion of study objectives.

• Ensure timely and accurate case report form (CRF) completion for each study subject.

• 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.

• Assess and record all adverse events as outlined in protocol.

• Report all serious adverse events to the principal investigator, sponsor's monitor, primary care physician, and IRB as outlined in the protocol.

• Maintain copies of all required regulatory documents in an organized manner.

• Attend and participate in weekly clinical research meetings, weekly general research meetings and weekly educational programs.

• Perform other duties as assigned.

Additional duties preferred (not required but a willingness to consider):

• Assist in preparing and submitting applications for IRB approval. This includes oversite waivers and full Human Subjects Protections proposals.

• Assist with evaluating study protocols for suitability. This includes determining cost effectiveness and manpower requirements. Work with sponsors to ensure protocol variable align with our procedures.

• Assist with evaluating studies with a keen insight as to the study population readily available for recruitment. This includes 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.

• Assist with negotiating study budgets with Sponsors to ensure study costs and personnel costs are adequately covered.

• Work with sponsors and the Office of Sponsored Programs with negotiation of the Clinical Trial Agreements.

• Help manage study duties among the research staff to best utilize their time and talents.

Qualifications

Bachelor's degree in science related field. Plus five (5) years of clinical practice or research experience. Previous experience with clinical research protocols required. Customer service-oriented individual is required.

Location : Location

US-VA-Norfolk