Coordinator, Operations Support
About The Position
Assists in the development of study documents and study preparation prior to the start of a study. Engages with CRCs (Clinical Research Coordinators) and study P.I.s during study preparation to ensure documents and procedures are documented in accordance with the protocol, GCP, and company SOPs. Manages the status and required items needed for studies involving the IRB, not limited to study submissions, deviation / SAE reporting, and study closeout. Engages with clients (when applicable) during study preparation phase to ensure all necessary documents (safety letter, informed consent, etc.) are finalized prior to IRB submission. Assists in the review and/or development of new protocols, assessments, procedures, and technologies. Assist with the development and updating of SOPs, WI, and training material related to study paperwork creation and IRB management. Ensure compliance with regulations. Provides excellent customer service to clients, and maintains positive interaction with peers and supervisors Adheres to internal standards, policies, and procedures.
Requirements
- Bachelor’s Degree, preferable in science or equivalent degree research organization, and/or prior project management experience.
- Ability to coordinate multiple projects at once.
- Ability to work independently, use time wisely and multi-task.
- Previous IRB experience and / or clinical research regulatory experience.
Nice To Haves
- CCRC or CCRA Certification preferred
Responsibilities
- Assists in the development of study documents and study preparation prior to the start of a study.
- Engages with CRCs (Clinical Research Coordinators) and study P.I.s during study preparation to ensure documents and procedures are documented in accordance with the protocol, GCP, and company SOPs.
- Manages the status and required items needed for studies involving the IRB, not limited to study submissions, deviation / SAE reporting, and study closeout.
- Engages with clients (when applicable) during study preparation phase to ensure all necessary documents (safety letter, informed consent, etc.) are finalized prior to IRB submission.
- Assists in the review and/or development of new protocols, assessments, procedures, and technologies.
- Assist with the development and updating of SOPs, WI, and training material related to study paperwork creation and IRB management.
- Ensure compliance with regulations.
- Provides excellent customer service to clients, and maintains positive interaction with peers and supervisors
- Adheres to internal standards, policies, and procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
