Clinical Research Coordinator

Overview

The primary responsibility of the Clinical Research Coordinator is to coordinate the day-to-day administrative and operational logistics of assigned 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.

Please note, this position is coterminous with grant funding.

Responsibilities

• Possess a sound and in-depth understanding of each study protocol that has been assigned as a primary responsibility. Review with the principal investigator and other study staff the inclusion/exclusion criteria, overall structure, and requirements of each protocol. Serve as the main point of contact with the study sponsors. Attend study-related meetings as appropriate. Coordinate the activities of various research team members to ensure completion of study objectives.
• Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and study staff, as appropriate. The coordinator reviews all eligibility requirements with the study participant and reports this to the Principal Investigator, who makes the final eligibility approval. Schedule subjects for screenings and follow-up visits. Maintain telephone contact with subjects in between visits, as needed.
• 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. Develop and distribute study materials to participants as needed.
• Ensure appropriate specimen collection. Experience with phlebotomy and processing/shipping of specimens highly desired. Review laboratory data and communicate abnormal values to the primary care provider and investigator for final sign off.
• Provide maintenance of medication/drug inventory/storage as well as investigational product accountability/dispensation logs. Coordinator will document and report all noted adverse events as well as notifying the study sponsor and/or site investigator.
• Ensure adherence to protocol requirements and that the randomization procedure is followed as per protocol guidelines. Document protocol exemptions and deviations, as appropriate.
• 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. Communicate regularly with the principal investigator about study-related issues.
• Submit all study materials to the appropriate IRB for approval. Submit amendments, continuing review reports and adverse events to the IRB.
• Maintain source documentation for all CRF entries, including clinic chart visit notes, lab data, and procedure reports. Ensure timely and accurate case report form (CRF) completion for each study subject and provide auditors with completed CRFs, medical records, lab data and other source documents for review. Maintain copies of all required regulatory documents in an organized manner.
• Complete and pass the required courses/tests/certificates and human subjects/ethics training courses.

Qualifications

Minimum Qualifications and Skills:

• Bachelor's degree
• Three (3) years of experience in clinical research protocols
• Previous experience with clinical research protocols preferred. Ability to think and work independently, insight, excellent organizational skills, astute and accurate patient assessment skills, and the ability to identify and assign priorities.

Preferred Qualifications:

• Experience in cognitive impairment/dementia research highly desired
• Five (5) years of clinical research experience

Location : Location

US-VA-Norfolk