Clinical Research Regulatory Specialist I, College of Medicine, Internal Medicin

About This Opportunity

We are representing a confidential academic medical organization seeking a Clinical Research Regulatory Specialist I to manage regulatory operations for assigned research studies. This role offers the opportunity to work with cutting-edge clinical research while ensuring full compliance with federal and institutional requirements.

The position is primarily remote with occasional on-site requirements as needed in the United States. This is a full-time opportunity supporting internal medicine research programs.

Responsibilities

• Prepare and submit protocol-specific documentation to regulatory agencies and stakeholders, including research protocols, informed consent forms, and documents for study start-up, maintenance, and close-out
• Serve as liaison for designated research protocols and perform submissions to Institutional Review Boards (IRBs), including initial submissions, continuing reviews, amendments, reportable events, and closures
• Address regulatory issues involving research protocols; interpret and apply federal, state, and local regulations to ensure ethical research practices
• Maintain all regulatory documentation within existing systems (such as Complion) and secure document storage for studies of varying complexity
• Apply regulations and legislation regarding protection of human subjects, including federal policies, FDA requirements, and other compliance directives
• Assist with development and execution of research agreements related to conduct of research activities
• Coordinate and participate in site visits; communicate effectively with sponsors and contract research organizations (CROs)
• Interact with IRB contacts and sponsor representatives with appropriate supervision

What We're Looking For

Required:

• Bachelor's degree
• 1-2 years of relevant experience in clinical research or regulatory operations
• Understanding of Good Clinical Practice guidelines, Code of Federal Regulations, and regulatory compliance
• Excellent verbal and written communication skills with ability to interpret and apply institutional policies and federal, state, and local regulations
• Ability to manage multiple priorities, organize work, and meet deadlines
• Competence working both independently and as part of a team

Preferred:

• SOCRA or ACRP certification
• Experience with research and regulatory requirements in an academic or clinical setting
• Knowledge of clinical research, human subject research ethics, and IRB procedures
• Familiarity with clinical trials monitoring and regulatory documentation systems

Note: This position is not eligible for H-1B or J-1 visa sponsorship.

How We Work With You

When you apply through Get A Job.ai, our talent team will review your qualifications and conduct an initial screening. If you're a strong match, we will submit your profile to our client for consideration. Please do not contact the employer directly—all communication and coordination will flow through our recruiting team to ensure the best experience for everyone involved.

Pay

Compensation details will be discussed during the screening process and are competitive based on experience and qualifications.

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