Clinical Study Operations & TMF Administrator

Real Staffing; Cleveland (OH); On-site; USD 45,000 - 70,000; Full time

Job summary

Specialist Staffing Group is seeking a regulatory/clinical operations professional to maintain CTMS activities and ensure TMF completeness for assigned studies. Responsibilities include creating regulatory binders, tracking essential documents, and distributing safety materials to cross-functional teams.

The role also covers generating system reports, supporting study supply creation and distribution to sites, and assisting with device tracking and ordering as needed.

Responsibilities

• Work with Study Teams and partners to maintain and track relevant activities in CTMS.
• Creation/distribution of regulatory binders
• Timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
• Distribution of safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
• Creation and generation of system reports.
• Provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs
• Assist with Device tracking and ordering if required and if applicable.

Job description

Specialist Staffing Group is seeking a regulatory/clinical operations professional to maintain CTMS activities and ensure TMF completeness for assigned studies. Responsibilities include creating regulatory binders, tracking essential documents, and distributing safety materials to cross-functional teams.

The role also covers generating system reports, supporting study supply creation and distribution to sites, and assisting with device tracking and ordering as needed.