Manager- CCRM Clinical Research Operations

The Ohio State University

1d • Onsite

About The Position

Serves as Clinical Research Manager in the College of Medicine (COM) Center for Clinical Research Management (CCRM); participates in execution of activities in the CCRM Clinical Research Operations Office in collaboration with Directors-Clinical Research Operations; oversees multiple study teams and research groups developing and implementing plans to meet requirements of new studies; recruits, hires, trains, evaluates and directly supervises disease team research managers, specialized staff, lab personnel, and other clinical research staff, as needed; develops onboarding and training materials for newly hired research staff and investigators to ensure compliance with university policies as well as national and international research standards of conduct; develops and implements new research strategies; develops and steers policies, guidance, Standard Operating Procedures (SOPs), and workflows to promote adherence to institutional, national, and international research regulations/guidance for CCRM affiliated disease teams; drives study start up processes and provides solutions for overcoming barriers to study implementation; actively contributes to College of Medicine research initiatives and facilitates collaboration among Centers, Departments, Divisions, and Offices within the COM and OSUWMC as well as all other clinical research stakeholders within and external to the institution; promotes the research mission of the institution; oversees the development and implementation of processes to enroll and consent patients to clinical research for CCRM affiliated groups; oversees and monitors that research study deliverables are met, including but not limited to enrollment goals, data entry, IRB submissions, budget and contract processes; collaborates with investigators to provide operational feedback for research protocols and may assist with providing required information for the preparation of grant applications to obtain research funding; participates in writing articles for publication and presentation related to the conduct of clinical research or clinical research oversight/administration; conducts quality assurance reviews of research processes and data and provides guidance for corrective and preventative actions; ensures compliance to federal, state and local regulations and guidelines and serves as main point of contact for guidance related to clinical research conduct and compliance; Participates in and oversees audits and inspections by research sponsors and regulatory agencies.

Requirements

• Bachelor's degree or equivalent experience.
• 5 years of relevant experience required.
• Knowledge of clinical research regulations, guidelines & compliance issues required including Institutional Review Board (IRB) & federal or industry sponsor processes and requirements

Nice To Haves

• Advanced degree may be desirable.
• 8-12 years of relevant experience preferred.
• Experience in a progressively responsible administrative or management research capacity preferred
• Experience writing research grants and proposals strongly desired.
• ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification preferred and should be maintained.

Responsibilities

• Participates in execution of activities in the CCRM Clinical Research Operations Office in collaboration with Directors-Clinical Research Operations
• Oversees multiple study teams and research groups developing and implementing plans to meet requirements of new studies
• Recruits, hires, trains, evaluates and directly supervises disease team research managers, specialized staff, lab personnel, and other clinical research staff, as needed
• Develops onboarding and training materials for newly hired research staff and investigators to ensure compliance with university policies as well as national and international research standards of conduct
• Develops and implements new research strategies
• Develops and steers policies, guidance, Standard Operating Procedures (SOPs), and workflows to promote adherence to institutional, national, and international research regulations/guidance for CCRM affiliated disease teams
• Drives study start up processes and provides solutions for overcoming barriers to study implementation
• Actively contributes to College of Medicine research initiatives and facilitates collaboration among Centers, Departments, Divisions, and Offices within the COM and OSUWMC as well as all other clinical research stakeholders within and external to the institution
• Promotes the research mission of the institution
• Oversees the development and implementation of processes to enroll and consent patients to clinical research for CCRM affiliated groups
• Oversees and monitors that research study deliverables are met, including but not limited to enrollment goals, data entry, IRB submissions, budget and contract processes
• Collaborates with investigators to provide operational feedback for research protocols and may assist with providing required information for the preparation of grant applications to obtain research funding
• Participates in writing articles for publication and presentation related to the conduct of clinical research or clinical research oversight/administration
• Conducts quality assurance reviews of research processes and data and provides guidance for corrective and preventative actions
• Ensures compliance to federal, state and local regulations and guidelines and serves as main point of contact for guidance related to clinical research conduct and compliance
• Participates in and oversees audits and inspections by research sponsors and regulatory agencies

Benefits

• Eligible Ohio State employees receive comprehensive benefits packages, including medical, dental and vision insurance, tuition assistance for employees and their dependents, and state or alternative retirement options with competitive employer contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager