What are the responsibilities and job description for the Manager- CCRM Clinical Research Operations position at Inside Higher Ed?
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Department:Medicine | Center for Clinical Research Management
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.
Minimum Education Required
Bachelor's degree or equivalent experience.
Preferred Education
Advanced degree may be desirable.
Required 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
Preferred Experience
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.
Certification Preferred
ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification preferred and should be maintained.
FUNCTION/SUBFUNCTION: Research Administration/Research Administration Management
CAREER LEVEL: People Leader- Managerial
CAREER BAND: M2
Additional Information
This position will require some travel to outpatient locations where clinical research is being performed. The locations may include Outpatient Dublin, New Albany, Outpatient Care East, East Hospital, Martha Morehouse Pavillion, Upper Arlington, etc.
This is not a remote position and is required to be on campus.
Location:Davis Heart and Lung Research Institute (0113)
Position Type:Regular
Scheduled Hours:40
Shift:First Shift
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions.
The university is an equal opportunity employer, including veterans and disability.
Current Employees And Students
If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process.
Welcome To The Ohio State University's Career Site. We Invite You To Apply To Positions Of Interest. In Order To Ensure Your Application Is Complete, You Must Complete The Following
- Ensure you have all necessary documents available when starting the application process. You can review the additional job description section on postings for documents that may be required.
- Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application.
Department:Medicine | Center for Clinical Research Management
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.
Minimum Education Required
Bachelor's degree or equivalent experience.
Preferred Education
Advanced degree may be desirable.
Required 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
Preferred Experience
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.
Certification Preferred
ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification preferred and should be maintained.
FUNCTION/SUBFUNCTION: Research Administration/Research Administration Management
CAREER LEVEL: People Leader- Managerial
CAREER BAND: M2
Additional Information
This position will require some travel to outpatient locations where clinical research is being performed. The locations may include Outpatient Dublin, New Albany, Outpatient Care East, East Hospital, Martha Morehouse Pavillion, Upper Arlington, etc.
This is not a remote position and is required to be on campus.
Location:Davis Heart and Lung Research Institute (0113)
Position Type:Regular
Scheduled Hours:40
Shift:First Shift
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions.
The university is an equal opportunity employer, including veterans and disability.