Enter a job title or keyword

Research Regulatory Coordinator

Carle Health

Job Location:

Urbana, OH - USA

Monthly Salary: Not provided by the employer

Posted: 31 July 2026 (30+ days ago)

Application Deadline: 28 October 2026

Vacancies: 1 Vacancy

Job Summary

Overview

The Clinical Research Regulatory Coordinator is a specialized research professional that facilitates and coordinates the regulatory aspects of a clinical trial and plays a critical role in the conduct of research at Carle. This role is responsible for preparing completing and submitting required forms and documents in consultation with the research team to meet regulatory IRB and HIPAA guidelines and policies at the time of initial review modifications and continuing review. The Clinical Research Regulatory Coordinator performs Informed Consent review and modifies consent form/HIPAA language while working with sponsors and IRBs for all studies to conform to Carle institutional guidelines.

Responsibilities

Prepares completes and submits required forms and documents in consultation with the research team to meet regulatory IRB and HIPAA guidelines and policies at the time of initial review modifications and continuing review.
Performs Informed Consent review and modifies consent form/HIPAA language while working with sponsors and IRBs for all studies to conform to Carle institutional guidelines. Ensures consent language matches the research contract budget and protocol.
Completes submits and maintains regulatory documents as applicable (including 1572s Delegation of Authority logs Financial Disclosure Forms Consent Forms and trainings) for industry sponsored as required.
Prepares for and participates in external sponsor/monitor visits. Prepares for and participates in internal/external audits to ensure regulatory compliance and implement corrective and preventive action plans as needed.
Updates and maintains current protocol information on the Research website. Distributes protocol documents to appropriate researcher and PI for review approval and implementation.
Tracks study approvals and expirations to ensure uninterrupted project approval. Maintains regulatory database and manages electronic filing of all regulatory documents.
Creates submits and maintains complete documentation to comply with research base regulatory requirements for oncology federally funded research projects
Trains/assists new/seasoned Staff on regulatory process including CITI training Study start-up IRB submissions maintaining a Study and ensuring all essential documents are correct to submit to monitor/sponsor.
Advises on remedies and revisions in collaboration with the coordinator and/or investigator and resolves any procedural issues that might arise in order to ensure timely IRB review
Updates and maintains the active informed consent documents and HIPAA authorizations that are being utilized in projects in which subjects are consented (whether Carle research is assisting with consenting or not)
Notifies appropriate staff physicians investigators and affiliates of protocol activations and closures in a timely manner
Facilitates study closure in collaboration with investigator research coordinator and sponsor
Applies rules and regulations (Carle local state federal industry sponsor etc.) in collaboration with the Sr Clinical Research Regulatory Coordinator and recommends and guides principal investigators (PIs) and research staff in the creation submission documenting reporting etc. of study activities ensuring appropriate compliance
Monitors Investigator Initiated IRB-deferred studies exempt and non-engaged projects for by ensuring regulatory documentation is current and maintained including any IRB approvals

Qualifications

Certifications: Certified Clinical Research Professional (CCRP) within 3 years - Society of Clinical Research Associates (SOCRA)Society of Clinical Research Associates (SOCRA) Education: Experience In Lieu of Education: Related Field; Bachelors Degree: Related Field Work Experience: Related field

Carle Health Company Overview

Find it here.

Discover the job the career the purpose you were meant for. At Carle Health were committed to fostering a workplace where every team member feels valued respected and empowered where passion and purpose come together to positively impact the lives of our patients and our communities. Find it all at Carle Health.

Our nearly 17000 team members and providers work together to support patient care across central and southeastern Illinois. Weve grown to include eight award-winning hospitals and a multispecialty provider group with more than 1500 doctors and advanced practice providers. Were developing the next generation of providers and healthcare professionals through Carle Illinois College of Medicine the worlds first engineering-based medical school and Methodist College. Carle BroMenn Medical Center Carle Foundation Hospital Carle Health Methodist Hospital Carle Health Proctor Hospital Carle Health Pekin Hospital and Carle Hoopeston Regional Health Center hold Magnet designations the nations highest honor for nursing care. We offer opportunities in several communities throughout central Illinois with potential for growth and life-long careers at Carle Health.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race color sex age national origin religion sexual orientation gender identity status as a veteran and basis of disability or any other federal state or local protected class. Carle Health participates in E-Verify and may provide the Social Security Administration and if necessary the Department of Homeland Security with information from each new employees Form I-9 to confirm work authorization. For more information:

Salary Range

The compensation range for this position is $25.81per hour - $43.1per hour. This represents a good faith minimum and maximum range for the role at the time of posting by Carle Health. The actual compensation offered a candidate will be dependent on a variety of factors including but not limited to the candidates experience qualifications location training licenses shifts worked and compensation model.

Carle Health offers a comprehensive benefits package for team members and providers. To learn more visit

Required Experience:

Apply Now