Research Regulatory Consultant

OhioHealth; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

OhioHealth is seeking a Regulatory Consultant to oversee pre-award and post-award activities for clinical trials and research projects. You will support system-wide research activities, develop regulatory documents, and ensure compliance with GCP and CFR standards.

Responsibilities include coordinating with investigators, liaising with sponsors, maintaining regulatory files, and guiding staff on regulatory requirements.

Qualifications

• Bachelor's Degree in Biological sciences, Administration, or related field.
• Associate's Degree with 3-4 years clinical research experience.
• 2 years of hospital/clinical or administrative experience.
• Certification as a clinical research coordinator (ACRP or SoCRA) or eligible.

Responsibilities

• Coordinate projects with researchers and staff; align with PI decisions and data collection.
• Ensure RMH education on research regulations is completed.
• Maintain confidential data collection forms, proposals, and final reports per policies.
• Liaise with trial sponsors during regulatory submissions and manage site documents.
• Initiate new study regulatory files in line with SOPs and CFR.
• Serve as a resource on regulatory concerns for staff.
• Audit projects for compliance with human subjects regulations as needed.
• Prepare and update databases related to research patients.
• Assist in accounts payable/receivable for trials and liaise with accounting.

Skills

Regulatory knowledge

IRB coordination

Clinical research coordination

Documentation management

Education

Bachelor's Degree (Required)

Associate's Degree with 3-4 years clinical research experience

Certification in clinical research coordination (ACRP/SoCRA) or eligible

Tools

Database software

Spreadsheet software

Word processing software

Clinical trial management systems

Job description

We are more than a health system. We are a belief system. We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more – in our careers and in our communities.

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.

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 hospital's 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 ensure 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 Research Administration

Other Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications.

Responsible for completing all necessary training for their position.

Maintain familiarity with evolving regulatory and compliance context.

Other duties as assigned.

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 ensure 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.

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

Equal Employment Opportunity

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.

About Us

WE Are Inspired to Do Our Best. OhioHealth is a nationally recognized, innovative healthcare system delivering world‑class patient care in a supportive, professional environment filled with limitless opportunities to learn and grow. We are a unique organization in the healthcare field. Our model system of facilities encompasses a wide scope of expertise and care. For professionals, we are a place where people committed to doing their best are given the tools and resources to accomplish our mission every single day. OhioHealth is recognized as a Great Place to Work CertifiedTM organization. The Great Place to Work® is a global authority on high‑trust, high‑performance workplace cultures. This recognition is one measure of our success in achieving a part of our vision ̶ to be an organization "where people want to work."