Position Summary

To serve as coordinator for clinical research studies and provides support to other study team members for research trials, studies, and projects within the confines of the study protocols as directed. To support protocol screening and study participant eligibility determination, working with more senior study team members to ensure compliance. To conduct all study activities in accordance with the protocol, Institutional Review Board (IRB) regulations, and Good Clinical Practice (GCP). May provide quality care to participants and their families within the area of clinical specialty. To assist with the life cycle of the study from start-up through maintenance to closure. To coordinate and organize participant care including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires. To perform the informed consent process following GCP. To act as a liaison among the clinical and research staff, departments, ancillary services and the study sponsor to ensure protocol compliance throughout the study.

Duties and Responsibilities

• Follows the patient from referral through treatment, discharge, and follow-up while providing patient and family education.
• Maintains clinical records and documentation.
• Performs routine and complex clinical procedures as required by the protocol.
• Employs strategies to maintain recruitment and retention rates.
• Prepares for study monitoring visits.
• Assists with correcting findings.
• Develops or provides input for IRB documents.
• Assists with the management of investigational products (IP) as needed.
• Develops study source documentation.
• Assists with the development of standard operating procedures (SOPs) for data quality assurance.
• Assists with study budgets as needed.
• Participates in study meetings and conference calls.
• Coordinates scheduling for participant visits among Principal Investigator (PI), pharmacy, or others as needed.
• Uses the electronic medical record (EMR) as needed, including reporting procedure results.
• Processes payments as needed and stays familiar with institutional financial systems.
• Performs other duties as assigned.

Annual Pay Range: $52,555 - $85,400

Qualifications

Bachelor's degree in a related field is required. Work experience may substitute for education requirements. Currently licensed or eligible to be licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.