Clinical Research Project Manager, Clinical Trials Unit (Hybrid)

University Hospitals Pain Management; Cleveland (OH); On-site; USD 70,000 - 105,000; Full time

Job summary

University Hospitals Pain Management in Cleveland, OH, is seeking an Administrative Research Trials Manager to oversee single and multi-institution trials and coordinate daily operations across sites, sponsors, and UH. This role ensures regulatory alignment and facilitates communications for study progress and updates.

You will coordinate protocol development, regulatory document handling, site startup and maintenance, and oversee a research team responsible for data input, analysis and

Responsibilities

• Oversees the administrative functions of single and/or multi-institutional research trials. Coordinates/manages daily organization and operational activities related to Phase I–IV clinical research trials. Facilitates key trial communications between the different participating institutions, sponsors and UH.
• Coordinates development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by IRB, sponsor and FDA. Collect and review regulatory documents from sites.
• Track and provide oversight for the start-up and maintenance of trial activities, enrollment, safety issues and protocol adherence at the different participating institutions.
• Oversee and coordinate the clinical trials team (external study coordinators, database manager, researchers and statisticians) responsible for data input, analysis and reporting.
• Organize, coordinate and participate in training for the different participating institutions. Develops and maintains planned communication with sites (ie: study progress updates, newsletters, etc)
• Assesses investigator and site performance.

Job description

What You Will Do

• Oversees the administrative functions of single and/or multi-institutional research trials. Coordinates/manages daily organization and operational activities related to Phase I-IV clinical research trials. Facilitates key trial communications between the different participating institutions, sponsors and UH. (20%)
• Coordinates development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by IRB, sponsor and FDA. Collect and review regulatory documents from sites. (20%)
• Track and provide oversight for the start-up and maintenance of trial activities, enrollment, safety issues and protocol adherence at the different participating institutions. (20%)
• Oversee and coordinate the clinical trials team (external study coordinators, database manager, researchers and statisticians) responsible for data input, analysis and reporting. (10%)
• Organize, coordinate and participate in training for the different participating institutions. Develops and maintains planned communication with sites (ie: study progress updates, newsletters, etc) (10%)
• Assesses investigator and site performance. (10%)

Additional Responsibilities

• Performs other duties as assigned.
• Complies with all policies and standards.
• For specific duties and responsibilities, refer to documentation provided by the department during orientation.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.