Clinical Research Coordinator (Part-Time)
The Clinical Research Coordinator will perform duties related to the conduct of clinical trials in orthopedic surgery. Candidate will be responsible for all study coordination tasks for assigned studies, from pre-study planning preparation, screening and enrolling patients in trials, patient informed consent, scheduling and coordination of appointments.
Clinical research duties:
- Maintains a high level of knowledge and understanding of assigned protocols, including all protocol requirements for participant visits, obtaining informed consent, participant visit schedules, tests, procedures, laboratory information, and drug accountability requirements.
- Participation in the proper consenting of study participants.
- Coordinates and conducts participant care visits and assures all procedures are conducted in compliance with the clinical protocol.
- Interacts with Principal Investigator as needed to assure participant receives appropriate medical evaluation and care when needed; alerts Principal Investigator and study sponsor of serious adverse events and assures the proper reporting of adverse events.
- Responsible for maintenance of study source documents.
- Interacts with sponsor Clinical Research Associate to facilitate the sponsor monitoring and database review and completion.
- Attends sponsor Investigator/Study Coordinator meetings as needed for assigned protocols
- Conducts clinical research in compliance with all applicable regulations including GCP’s and company SOP’s.
- A Minimum of 2 years experience in clinical research required. Experience in medical device or Orthopaedics preferred.
- Clinical experience and / or knowledge and familiarity with GCPs required.
- CCRP or CCRC Certification preferred.
- BA/BS in science or related discipline required.
- Proficiency in Microsoft Word and Excel required.
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