Summary: The Clinical Research Coordinator will be the main operational interface with study subjects during the conduct of a clinical trial. The CRC will participate in and manage all administrative aspects of clinical trials communicating with Doctors, Nurses, and Sponsors daily. Performs duties satisfactorily in accordance with Good Clinical Practice Guidelines.

Responsibilities:

• Schedules subject appointments, performs subject reminder calls, and is point of contact for subject concerns or questions.
• Performs rounds in the clinic to check on subjects and review subject source for completion and protocol compliance.
• Reviews protocol for accuracy, logistics, and for training purposes.
• Assists with training or managing oversight of training compliance of specific protocol related items for the clinical site.
• Keeps the Investigator Site File updated with pertinent information.
• Responsible for managing study tracking tools, including study information files.
• Ensures subject study binders are prepared for study visits.
• Assists with the review of relevant documents for accuracy.
• Assists with review of regulatory binders for completeness and accuracy, as needed.
• Supports staff in day-to-day clinical or administrative activities and procedures.
• Supports staff in monitoring and recording subject response to treatment, questioning subjects on adverse events/serious adverse events during study, and completing study specific subject information on serious adverse event forms.
• Resolves study source document discrepancies including supervising and reviewing completion of documentation of discrepancies by clinical research staff.
• Assists with data entry, as needed.
• Attends clinical trial teleconferences and/or meetings.
• Schedules and organizes monitor and sponsor on-site visits, as needed, including setting up pharmacy, lab, and Principal Investigator (PI) meetings with the Clinical Research Associate.
• Under direction of the PI, creates Notes to File for clarification around subject related matters.
• Participates in study source review and approval processes.

Competencies:

• Patient Focus: Is dedicated to meeting the expectations and requirements of patient care; acts with patients in mind; establishes and maintains effective relationships with patients and gains their trust and respect; maintains patient privacy in all aspects of a clinical trial.
• Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Team Focus: Enjoys working together with others as a team and goes above and beyond to help accomplish goals in a team-oriented environment.
• Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
• Excellent communication skills (interpersonal, written, verbal).

Education and Experience:

• 3 years of experience as a CRC
• CRC certification preferred.
• Medical Office experience preferred.