Research Regulatory Coordinator

Carle Health; Urbana (IL); On-site; USD 35,817 - 59,236; Full time

Job summary

Carle Health in Illinois is seeking a Clinical Research Regulatory Coordinator to oversee regulatory aspects of a clinical trial, ensuring IRB, HIPAA, and sponsor requirements are met. You will prepare, complete, and submit forms at initial review, modifications, and continuing review, and review informed consent documents.

The role involves maintaining regulatory databases, coordinating audits and sponsor visits, training staff on regulatory processes, and guiding investigators to maintain

Qualifications

• CCRP certification within 3 years or SOCRA certification.
• Bachelor's degree in a related field or equivalent experience.
• Experience in regulatory documentation and study start-up.

Responsibilities

• Prepares, submits regulatory forms to meet IRB and HIPAA guidelines at initial review, modifications, and continuing review.
• Performs Informed Consent review and updates HIPAA language with sponsors and IRBs.
• Maintains regulatory documents (1572s, delegation logs, financial disclosures, forms, trainings).
• Prepares for sponsor/monitor visits and internal/external audits.
• Updates protocol information on the Research website and distributes documents for review.
• Tracks approvals/expirations to ensure uninterrupted study oversight.
• Maintains regulatory database and electronic filing of documents.
• Creates, submits, and maintains documentation for oncology federally funded projects.
• Trains staff on regulatory processes including CITI training, study start-up, IRB submissions.
• Advises on remedies and revisions to ensure timely IRB review.
• Updates active consent documents and HIPAA authorizations used in projects.
• Notifies staff of protocol activations/closures; facilitates study closures with investigators.
• Applies regulations and guides PIs/research staff to ensure compliance.
• Monitors Investigator-Initiated IRB-deferred studies for current regulatory documentation.

Skills

Informed Consent review

IRB coordination

HIPAA compliance

Education

CCRP certification (SOCRA)

Bachelor's Degree in Related Field

Related Field experience

Job description

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.

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; Bachelor's Degree: Related Field, Work Experience: Related field

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

About Us

Find it here.

Discover the job, the career, the purpose you were meant for. At Carle Health, we're 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 17,000 team members and providers work together to support patient care across central and southeastern Illinois. We’ve grown to include eight, award-winning hospitals and a multispecialty provider group with more than 1,500 doctors and advanced practice providers. We’re developing the next generation of providers and healthcare professionals through Carle Illinois College of Medicine, the world’s 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 nation’s 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 employee's Form I-9 to confirm work authorization. | For more information: [e-mail].

Compensation and Benefits

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 candidate’s 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 careers.carlehealth.org/benefits.