Job description
The Clinical Research Coordinator oversees and coordinates the daily activities of clinical research studies. They work closely with the clinical teams and investigators to ensure that all required procedures and visits occur according to protocol specific guidelines.
RESPONSIBILITIES
- Organize all aspects of the clinical trials assigned.
- Participate in investigator meetings, site initiation meetings, etc. as needed.
- Work with internal recruitment department for participant screening and enrollment and ensure compliance with protocol and all applicable regulations.
- Conduct informed consent process and conduct study related visits.
- Monitor subjects per protocol requirements.
- Assess, monitor, and report adverse events per protocol.
- Maintain required records of study activity including source documentation, case report forms, drug dispensation records, and data management system entry.
- Dispense test articles, calculate dosages if needed, and provide instructions.
- Complete case report forms and resolve queries.
- Report protocol deviations to PI, sponsor, and IRB as required.
- Obtain, process and ship study related specimens.
- Provide assistance to fellow study coordinators.
- Manage quality assurance activities for assigned protocols per site SOP’s.
- Ensure adherence to study protocols and study quality, and maintain subject confidentiality.
KNOWLEDGE, SKILLS, AND ABILITIES
- Must possess excellent leadership, organizational, computer, and communication skills.
- Ability to multi-task, prioritize appropriately, and work well both individually and as part of a team.
- Ability to use time productively and contribute to high levels of company operational efficiency and effectiveness.
- Ability to maintain confidentiality of information.
- Ability to communicate in an active multi-office environment.
- Ability to efficiently operate all job-related office equipment (telephone, computer, calculator, fax, copier, study-specific equipment).
Required Experience :
- Bachelor’s Degree Required
- MS, LPN, RN, or other medical license or certification preferred
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