Research Manager, Department of Medicine

Inspire health. Serve with compassion. Be the difference.

Responsible for the implementation, direction, execution and management of departmental research studies and the education of research staff and healthcare team members. Develops and maintains successful interdisciplinary relationships with the system and community and with sponsoring agencies. Develops and maintains a system to promote regulatory compliance. Develops and negotiates study budgets and manages clinical trial agreements (contracts). Proactively seeks new research grants.

Responsible for the oversight of the submission and maintenance of regulatory documents with an advanced knowledge of local and Federal requirements. Assists in plans for the development and direction of the Research Program. General managerial duties as required.

• All team members are expected to be knowledgeable and compliant with Prisma Health's purpose:
  Inspire health. Serve with compassion. Be the difference.
• Responsible for oversight of clinical research protocols. Serves as a key resource point-of-contact for clinical trials information.
• Responsible for the oversight of recruitment of clinical trials and research grant opportunities. Collaborates with medical staff to identify research opportunities to meet departmental needs.
• Trains and oversees Study Staff regarding institutional and federal regulations as they pertain to research. Develops opportunities for research staff to promote research excellence.
• Ensures appropriate reimbursement from sponsoring agencies and ensures appropriate reimbursement to research participants, as applicable. Monitors charges posted against research corporate accounts, resulting in reliable balances in grant expense accounts.
• Communicates with sponsoring agencies, study staff, investigators and with the IRC ensures global awareness regarding the progression of individual studies, including revisions/amendments and adverse events. Attends Investigator meetings as appropriate.
• Maintains familiarity with Institutional, State and Federal Regulations regarding patients' rights as they pertain to human subject research and oversees regulatory submissions and maintains regulatory documentation to ensure compliance with local, federal and institutional/guidelines requirements/regulations for the appropriate conduct of research.
• Assists in the development of the Departmental Research Program. Aligns Program goals with institutional and departmental vision. Assists in the development of and adherence to yearly departmental budgets.
• Maintains Research Standard Operating Procedures (SOPs) meeting FDA, IRC and GCP regulations/guidelines. Develops standard research practices that meet the Program, departmental and institutional needs.
• Arranges, prepares for and manages pre-site qualification visits, study initiation visits and close-out visits with the assistance of research staff and investigators. Coordinates various advertising venues dependent upon enrollment needs.
• Seeks and participates in opportunities to educate and develop a positive awareness of the research Program within the institution and department. Develops and maintains positive interdisciplinary and external relationships to ensure the appropriate conduct of clinical trials.
• Assists in identifying research projects to augment resident education and develop the research program as part of resident curriculum.
• Performs other duties as assigned.

• Job has direct and/or indirect supervision of employees that may include final budget authority, hire/termination authority, performance appraisal responsibility and disciplinary authority. Job will be considered a member of management staff and will have direct reports.

• Education - Bachelor's degree
• Experience - Five (5) years of clinical research and management experience

• In lieu of education and experience noted above equivalent combination of work and academic experience may be considered (i.e., nine years related work experience OR Associate degree and seven years of related work experience OR Master's degree and three years of…