Clinical Study 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

Deliverables:

• 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.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.