Clinical Research Coordinator

Position Summary

This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol.

Position Duties

• Ensures assigned studies are conducted in accordance with FDA, OHRP, GCP, and institutional guidelines.
• Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area.
• Completes all tasks required by study sponsors.
• Provides regulatory documents to sponsor in timely manner.
• Completes case report forms, data entry, and maintains source documentation for all study participants.
• Tracks and reports adverse events per sponsor and institutional guidelines.
• Captures and schedules a variety of medical procedures/tests including, but not limited to, laboratory tests, blood pressure readings, imaging studies, psychological evaluations, and cardiac and/or pulmonary function tests as needed by the study protocol(s).
• Participates in a variety of professional development programs to ensure understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area.

Position Qualifications

• Education: Bachelor’s degree in related field or equivalent combination of education and experience.
• Experience: One year of clinical research experience or equivalent clinical research training program approved by Director, Clinical Research Operations.
• Special Skills: Proven ability to successfully coordinate multiple studies adhering to regulatory and institutional guidelines; proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care.
• Additional Requirements: ACRP or SOCRA Clinical Research Certification preferred; Clinical Research Training Certification preferred; Phlebotomy Certification preferred.