Clinical Research Manager- Neurological Surgery

The Ohio State University

2d • Onsite

About The Position

Serves as Clinical Research Manager in the Department of Neurological Surgery and works conjunctively with the COM Center for Clinical Research Management (CCRM); participates in execution of clinical research activities in collaboration with site Principal Investigator(s); evaluates and implements designated aspects of new research strategies and protocol start-up; participates in developing and implementing processes to enroll patients to clinical trials to ensure consistency and integrity in eligibility determination, recruitment and subject management; collaborates with the CCRM to implement study participant consenting processes to comply with COM, sponsor and federal regulations; oversees and manages planning, implementation and execution of clinical trials within the Department of Neurological Surgery; plans and supervises daily administrative, research and patient care activities of the clinical research staff; oversees clinical research staff’s recruitment activity including, interviewing, screening and enrolling of patients into relevant protocols; assists with training and re-training of newly hired and current clinical research staff; supervises clinical research data collection, management, analysis and reporting; collaborates with investigators to develop research protocols and assists with writing and preparation of grant applications to obtain research funding; participates in writing and submission of manuscripts and articles for publication and presentation conducts quality assurance reviews of research processes and data; ensures compliance to federal, state and local regulations and guidelines; plans, coordinates and participates in site visits by research sponsors and regulatory agencies as needed; actively contributes to the COM and Department research initiatives.

Requirements

• Bachelor’s Degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required.
• 5 years of relevant experience required in a clinical research capacity conducting & implementing research projects 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

• 8-12 years of relevant experience preferred.
• ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification required and must be maintained.

Responsibilities

• Participates in execution of clinical research activities in collaboration with site Principal Investigator(s)
• Evaluates and implements designated aspects of new research strategies and protocol start-up
• Develops and implements processes to enroll patients to clinical trials to ensure consistency and integrity in eligibility determination, recruitment and subject management
• Collaborates with the CCRM to implement study participant consenting processes to comply with COM, sponsor and federal regulations
• Oversees and manages planning, implementation and execution of clinical trials within the Department of Neurological Surgery
• Plans and supervises daily administrative, research and patient care activities of the clinical research staff
• Oversees clinical research staff’s recruitment activity including, interviewing, screening and enrolling of patients into relevant protocols
• Assists with training and re-training of newly hired and current clinical research staff
• Supervises clinical research data collection, management, analysis and reporting
• Collaborates with investigators to develop research protocols and assists with writing and preparation of grant applications to obtain research funding
• Participates in writing and submission of manuscripts and articles for publication and presentation
• Conducts quality assurance reviews of research processes and data
• Ensures compliance to federal, state and local regulations and guidelines
• Plans, coordinates and participates in site visits by research sponsors and regulatory agencies as needed
• Actively contributes to the COM and Department research initiatives

Benefits

• Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost.
• Paid time off, including sick and vacation time and 11 holidays.
• State retirement plan or an alternative retirement plan, both with generous employer contributions.

What This Job Offers

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