Clinical Research Coordinator

Position Summary

The Department of Surgery is seeking an individual for the position of Clinical Research Coordinator (CRC) who is passionate about delivering high-quality work. The CRC will have strong organizational, multi-tasking, time management, communication, and interpersonal skills to join the Clinical Research Core in executing clinical trials for improving treatments and outcomes for patents. The position is responsible for collaborating with PIs, team members, clinicians, and sponsors as well as working independently. The CRC will report directly to the Director. The main role of the CRC will be to operate and maintain the day-to-day operational duties of their assigned clinical trials and clinical research study database.

Responsibilities

• Clearly and effectively communicate with potential study subjects, clinicians, and other health care providers, ancillary staff, sponsors, and research office staff.
• Complete and maintain the required training for participation in clinical research, including but not limited to, Human Subjects Protection training and Clinical Research Coordinator Course.
• Work with Regulatory team in submitting new protocols, amendments, renewals and other regulatory bodies.
• Work with Program Manager in preparation of study budgets, submitting pharmacy cost estimates, ensuring compliance with research billing and processing stipends for subjects? participation in studies.
• Coordinate day-to-day aspect of study related procedures, including, but not limited to scheduling visits and procedures, data entry, preparation for research visits, research visit documentation, maintenance of regulatory binders and study files, creation and/or maintenance of source documentation, and preparation for monitoring visits, site initiation/closeout visits and audits as needed.
• Rotate in an ?on call? system for studies where research procedures are required on weekends or after hours.
• Prepare for, participate in, contribute to meetings with the Core, PIs, and sponsors.

Minimum Qualifications

Minimum education:

• Requires a Bachelor's Degree or equivalent in education and experience.

Other Requirements

Qualifications for Candidates include but are not limited to the following:

• Working knowledge of MS Office, specifically Word and Excel is required.
• Candidate will ensure integrity and compliance with all regulatory, institutional, and departmental requirements.
• The ability to take initiative and work independently is required.
• The ability to effectively work in a complex matrix is required.
• Outstanding technical writing skills and understanding of medical terminology/research.
• Advanced understanding of data management processes.
• Ability to analyze and interpret scientific data and skilled in the use of computerized systems and databases.
• Ability to understand and follow scientific research protocol and procedure.
• Excellent communication skills (both verbal and written) required.
• Exceptional organizational, interpersonal, and presentation skills.
• Ability to understand and follow complex, detailed technical instructions.
• Ability to foster a cooperative and collaborative work environment.
• The ability to be flexible with scheduling is mandatory; willingness to work evenings and weekend hours in unusual or emergent situations required.