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Job Description Summary:

The Consultant, Regulatory will provide regulatory management oversight for pre-award and post-award activities for clinical trials and research projects to provide system-wide support of OhioHealth research activities in accordance with Good Clinical Practices (GCP) Activities include a variety of complex and varied regulatory and administrative support functions such as analyzing protocols, developing informed consent documents, developing and maintaining study regulatory documents, establishing and maintaining comprehensive regulatory recordkeeping systems, preparing study amendments, and maintaining regulatory oversight functions across OhioHealth research sites. The person in this position provides compliance oversight and guidance and communicates and interprets agency policies and requirements for research personnel. This includes acting to improve internal processes when possible, follow-up and management of research files.

Minimum Qualifications:

Bachelor's Degree (Required)

• Field of Study: Biological sciences, Administration, or related field
• OR Associate's Degree with 3 to 4 years clinical research experience
• Years of experience: 2 years of experience in hospital/clinical or administrative setting.

SPECIALIZED KNOWLEDGE
Field of Study: Biological science, Administration or related field or an Field of Study: a related field, 3 -4 years of clinical research Experience and possess Certification as a clinical research coordinator (e. g. , ACRP or SoCRA) or currently eligible to obtain the Certification . Medical terminology, proficiency in database, spreadsheet and word processing software. 4 years Experience in hospital/clinical setting, work Experience with physician contact.

DESIRED ATTRIBUTES
Certified clinical research coordinator (e. g. , ACRP, SoCRA) knowledge of federal regulations on human subject research, IRB regulations 1-2 years in research setting, experience with budgeting



RESPONSIBILITIES AND DUTIES

30%
Project coordination works with research nurses and physicians to implement study procedures; consult with principal investigator in project decision-making; assigns work to project staff; orients and instructs investigators and staff on data collection and project record-keeping procedures. . Ensures investigators have undergone RMH-required education on research regulations. Maintains and stores confidential data collection forms, proposals and final reports in accordance with the hospitals research policies. . Acts as a Liaison with the trial sponsor during the regulatory submission process, collects, organizes, logs, files and transmits all required site & investigator documents. Initiates new research protocol regulatory files in compliance with department SOPs and the Federal Code of Regulations. Acts as a resource to clinical research staff on research regulatory concerns. May be asked to internally audit projects to ensures studies are conducted in accordance with federal regulations related to human subjects research. Prepares, maintains and updates computerized database pertaining to research patients. May assist in coordinating accounts payable/receivable for clinical trials involving pharmaceutical companies and consortiums. May act as liaison between accounting and finance.
20%
Project Planning facilitates multidisciplinary research team; assesses feasibility of research projects; designs data collection processes. Reviews project proposals for completeness and appropriate formatting. Conducts initial review and dissemination of research protocols, protocol revisions, protocol amendments and obtains opinions from others, when appropriate.
50%
Liaison with Institutional Review Board on ethical matters regarding hospital-sponsored human subjects research; responds to IRB correspondence and determination letters. Prepare proposals applications and submissions to the appropriate institutional review board . . Responds to requests for information which originate from other hospital departments, investigators and outside sponsors concerning status of IRB approval.

Work Shift:

Day

Scheduled Weekly Hours :

40

Department

Academic Research

Join us!
... if your passion is to work in a caring environment
... if you believe that learning is a life-long process
... if you strive for excellence and want to be among the best in the healthcare industry

Equal Employment Opportunity

OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment