Clinical Research Regulatory Specialist

Medasource; Cincinnati (OH); Remote; USD 65,000 - 85,000; Full time

Job summary

A leading company is seeking a Clinical Research Regulatory Specialist for a 2-3 month contract with the possibility of extension. This role involves oversight of regulatory compliance in clinical trials associated with Kettering Health and requires solid experience in clinical trial management and GCP standards. The position is remote, requiring alignment with Eastern Standard Time hours. Ideal candidates will hold a Bachelor's degree in a science or allied health major, with a preference for those with a Master's degree and appropriate clinical trial certifications.

Qualifications

• A minimum of 2 years of clinical trial experience required.
• Master’s degree preferred for advanced roles.
• Nursing or other health professional licensure preferred.

Responsibilities

• Provide centralized study supervision and support for coordinators and investigators.
• Manage compliance of regulations and Good Clinical Practice.
• Prepare and maintain regulatory documents for clinical trials.

Skills

Regulatory compliance

Clinical trial management

Good Clinical Practice (GCP)

Document management

Education

Baccalaureate degree

Master’s degree (preferred)

Job description

Clinical Research Regulatory Specialist

Duration: 2-3 month contract to start, likelihood of extensions/conversion

Start: ASAP

Interview Process: 1-round

Location: 100% Remote, but must be willing to work EST hours

JOB SUMMARY:

Under the supervision of the Manager, Research Operations, the Regulatory Compliance and Start-up Operations Specialist is responsible for the oversight of regulatory and start-up study operations for the onsite and offsite staff conducting research in association with Kettering Health (KH). NRC’s responsibilities include the management and regulatory documentation of clinical trials within the KHN.

The Regulatory Specialist will provide centralized support, training, communication, and coordination for study coordinators and study investigators, and appropriate departments that assist with research endeavors,throughout the start-up phase of a research study, which include protocol development, IRB submission and tracking, and managing compliance issues to ensure that the rights and well-being of human subjects are protected and that the conduct of the research is in compliance with the currently approved protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.

Additional responsibilities include leadership input in decision making and the hiring process.

The Regulatory Specialist will collaborate with physicians, scientists, administration, Institutional Review Boards (IRB), sponsors, and the Food and Drug Administration (FDA) in conducting clinical research per Good Clinical Practices (GCP) guidelines as set forth by the Federal regulations. This includes ensuring that that research personnel have completed all required educational, regulatory and conflict of interest training per company policy.

The Regulatory Specialist will also be responsible for the preparation, submission and tracking of all regulatory documents relative to conducting clinical trials. Under the supervision of the Manager, Research Operations, the Regulatory Specialist will collaborate with research team members, regulatory bodies, including local and central IRBs, and research sponsors in ensuring compliance with the regulatory requirements essential to the protection of human subjects in the ethical conduct of research. Essential to this role is the creation and management of all required regulatory documents per FDA/ICH Good Clinical Practice (GCP) standards. Document management includes preparation, submission, routing and distribution to all applicable parties, internal and external, in a timely and accurate manner. The Regulatory Specialist will also coordinate site qualification and study initiation visits with the study sponsor. The Regulatory Specialist will coordinate with research team members in the submission and tracking of external safety reports and internal serious adverse event reports to the respective IRB, local or central. The Regulatory Specialist will serve an integral role as a research team member, supporting and promoting compliance with regulatory standards, and other duties as assigned.

KEY JOB RESPONSIBILITIES:

• Providing centralized study supervision, support, training, communication, and coordination for study coordinators, study investigators, and appropriate departments throughout the start-up phase of research studies.
• Managing compliance of regulations, Good Clinical Practice, and human subject protections.
• Preparing, submitting, maintaining, and tracking all regulatory documents relative to conducting clinical trials and FDA submissions, including radiopharmaceutical INDs, Expanded Access, and others as applicable.
• Liaison for ancillary services, including local IRB, institutional pharmacy, and institutional laboratory.
• Ensure oversight of Investigator-Initiated trials and external research coordinators and community partners.
• Lead technology enhancements and implementations for department.

REQUIREMENTS:

Education: Baccalaureate degree required; science or allied health major desired; Master’s degree preferred.

Experience: At least 2 years of clinical trial experience through exposure to protocols in various therapeutic areas. Introductory supervisor in a research setting for a minimum of 2 years desirable. Clinical trial regulatory experience strongly preferred.

Licensure, Certifications, Registrations: Nursing or other health professional licensure is preferred. Current certification as Certified Clinical Research Professional (CCRP) or Clinical Research Associate (CCRA) is preferred.