Regulatory Manager

Johnson County Clintrials LLC•Houston, TX

About The Position

The purpose of the Regulatory Administrator is to ensure the ethical, compliant, and efficient conduct of clinical research by managing all regulatory documentation, safety reporting, and study-startup activities across assigned protocols. This role safeguards adherence to federal, state, and international regulations while maintaining accurate, organized regulatory records and serving as a key liaison among investigators, study teams, sponsors, IRBs, and regulatory agencies. Through expert coordination, clear communication, and a commitment to quality, the Regulatory Administrator supports operational excellence, protects research participants, and enables the successful execution of clinical trials. The Regulatory Administrator position is responsible for performing study-specific regulatory and safety reporting across multiple studies. This position assures that the research conducted is compliant with applicable federal, state or international requirements. The Regulatory Administrator position is the assigned contact for study-start up activities including IRB/Ancillary committee submissions and maintenances of regulatory records throughout the life of an assigned protocol. This position reports to the Site Director, VP Study Management.

Requirements

Associates degree plus two years’ related work experience or an equivalent combination of relevant post-secondary education and work experience that equals 4 years is required
Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research
Previous experience in a clinical research setting or related work environment
Familiarity with and/or the ability to learn clinical trial management system software
Excellent communication, interpersonal, analytical and problem-solving skills
Microsoft Office Suite proficiency
Writing and verbal communication skills
Knowledge of medical terminology and concepts
Proficient typing and data entry skills
Ability to work effectively with a team
Ability to manage small projects personally and work independently
Memory to retain information and know where to research answers
Time management skills
Organizational skills
Detail oriented with the ability to perform at a high level of accuracy
Demonstrates strong analytical, problem-solving skills
Self-motivated
Must be results oriented, multi-tasking, quick learner
Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
Ability to lift and/or move up to 20 pounds

Nice To Haves

Bachelor’s degree is preferred

Responsibilities

Compiles, reviews and files all required clinical trial regulatory documents
Maintains well organized study binders and provides timely, professional assistance to pharmaceutical companies and government agencies during monitoring visits and audits
Obtains essential documents for each study including CVs, medical licenses, laboratory certifications, training documents and all other documents that are required
Prepares development and makes submissions of all regulatory documents including submission of study documents to the Institutional Review Board
Communicates promptly and effectively with the IRB, sponsors and regulatory agencies
Collaborate with team members to ensure that regulatory documents are completed and accurate
Maintains the trial master file and/or regulatory binders
Aids study monitors during routine monitor visits or audits
Maintains regulatory records throughout the life of the trial
Updates protocol-specific systems with complete and accurate protocol and study information
Works closely with Investigators, study personnel and study sponsors on relevant regulatory and/or safety concerns
Establishes and enforces procedures that ensure staff members are fully compliant with all laws, regulations, SOPs, and other applicable guidelines
Provides ample support for staff that report into the regulatory position including performance-based coaching
May have direct reports to manage and mentor
Motivates and inspires employees to do their best work through leading by example
Other duties as assigned