Clinical Research Coordinator
The Clinical Research Coordinator (CRC) works with and under the direction of the Principle Investigator. The CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC monitors to ensure productivity and timely completion of studies.
- Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and other appropriate offices.
- Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.
- Develops accurate source materials and ensures compliance from staff.
- Provides accurate and timely data collection, documentation, entry, and reporting in appropriate database(s).
- Ensures appropriate credentialing and training.
- Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol
- Collaborates with PI to respond to any audit findings and implement-approved recommendations.
- Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, Physicians, and study participants.
- Ensures compliance with research protocols by providing ongoing quality control audits.
- Possible travel
- Other duties as assigned
- Candidates with a Bachelor’s degree in a scientific, health related, or business administration program, preferred.
- Preferred candidates will have three or more years as a clinical research professional (certification, as a CCRC desired).
- CPR-certification required
- Knowledge of medical terminology, clinical medicine, clinical trials.
- Detail-oriented and meticulous in all aspects of work
- Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
- Must have professional demeanor and strong communication skills with the public as well as physicians/researchers
- Ability to work well independently as well as in team environment
- Strong interpersonal, customer service, and multi-tasking skills are critical
- Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire
- Ability to be flexible, organized, detail-oriented and tenacious in follow-through
- Possess the ability to work well under pressure, multi-task and manage deadlines Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedure