The Office of Research Compliance (ORC), under the auspices of the Office of Research and the Office of University Compliance & Integrity, works with various Ohio State stakeholders and researchers to help minimize and manage potential compliance risks in regulatory areas impacting their research activities. ORC reviews and investigates allegations of misconduct in research and scholarly activities; oversees and manages the research Financial Conflict of Interest process; manages the National Security and Export Control programs; and oversees and manages a variety of other programs and policies involving research.
The Office of Research Compliance (ORC) is seeking a self-motivated, independent, effective communicator, and resourceful individual to function as Director of Clinical Research Compliance & Operations within the Office of Research.
The position reports to the Associate Vice President, Office of Research Compliance, and works in collaboration with the College of Medicine & Office of Health (COM/OHS), the Wexner Medical Center, the Comprehensive Cancer Center, the Clinical Trials Office (CTO), the Clinical Trials Management Operations (CTMO), the Office of Compliance and Integrity and others to identify, develop, direct and oversee a university-wide clinical research compliance program. This program will be instrumental in creating a university-wide governance and management model for all clinical trials operations. The director will also develop an implementation plan, establishing the authority and long-term management of these strategies. Collaborating and obtaining support from key stakeholders is a critical component to develop and sustain this plan.
Job Performance Objectives
1.To design, establish and monitor clinical research compliance systems using industry best practices in order to establish a framework outlining operational objectives and standards. Including developing and implementing policies & procedures to ensure compliance to local, state and national research & sponsor guidelines and regulations regarding clinical research; directing & conducting periodic clinical research compliance quality assurance reviews & physical audits to ensure human subject protection & regulatory compliance; planning, designing and conducting training and continuing education programs; and, monitoring and tracking completion of required training programs.
2.To lead and oversee clinical research compliance initiatives; collect, analyze and interpret data to support clinical research compliance plans; perform risk assessments and gap analysis; prepare compliance reports and present to senior leadership and research teams.
3.Identify needs to revise clinical research compliance programs and advise key research entities.
4.Collaborate with information technology teams to develop electronic solutions for clinical research community.
5.Plan, develop, and oversee clinical research mission communication & marketing strategies; continuously monitor and review regulations, policies, ethical guidance and requirements related to the conduct of human subject research.
Additional Information for Applicants
A resume and cover letter are required to be submitted to be considered for this position.
The individual in this position must have demonstrated and possess the following skills and abilities in order to be successful in this role:
Strong relationship building capabilities, values knowledge sharing and effective interpersonal skills to effectively engage and work collaboratively with various individuals and groups across the university.
Superior outreach, customer service, communication, writing, and organizational skills.
Manage work assignments efficiently while working autonomously, but also within a team environment.
Apply judgment and have the ability to be tactful in relaying decisions and handle sensitive and confidential information with appropriate discretion.
Be enthusiastic, positive, and independent, takes the initiative, and must be a problem solver seeking solutions to complex issues.
Bachelor’s degree in a biological or health related science or equivalent combination of education & experience; considerable experience in clinical research setting; experience in research management or administration capacity and preferably in regulatory & compliance; considerable knowledge of Ohio State University research policies & procedures, FDAOHRP and DHHS regulations, Good Clinical Practices, & HIPAA regulations for human subject research.
Requires successful completion of a background check; qualified candidates may be asked to complete a pre-employment physical, including a drug screen.
Master’s degree in biological or health related science highly desired; Certifications from Association of Clinical Research Professionals (ACRP), or Society of Clinical Research Associates (SoCRA) preferred.
Target Salary: $99,000.00 - $121,000.00 Annually
Job Category: Administrative and Professional
Job Appointment (FTE%):
The Ohio State University is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation or identity, national origin, disability status, and protected veteran status.
The Ohio State University is a dynamic community of diverse resources, where opportunity thrives and where individuals transform themselves and the world. Founded in 1870, Ohio State is a world-class public research university and the leading comprehensive teaching and research institution in the state of Ohio. With more than 63,000 students (including 57,000 in Columbus), the Wexner Medical Center, 14 colleges, 80 centers and 175 majors, the university offers its students tremendous breadth and depth of opportunity in the liberal arts, the sciences and the professions.