Regulatory Manager at Johnson County Clintrials LLC

Houston, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

21 May, 26

Salary

80000.0

Posted On

20 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Documentation, Safety Reporting, Study Startup, IRB Submissions, Record Maintenance, Communication, Coordination, Compliance, Audits, Data Entry, Analytical Skills, Problem-Solving, Time Management, Organizational Skills, Detail Oriented, Self-Motivated

Industry

Research Services

Description

Description Position: Regulatory Manager Location: Juno Research (JCCT) Houston, TX Department: Regulatory Purpose: 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. Position Summary: 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. Key Responsibilities (Essential Functions): 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 Education and Experience: 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 Bachelor’s degree is preferred 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 deadlines Skills and Competencies: 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 Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. 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 Why JCCT? JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States. We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment. Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors. If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today! EEO JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Responsibilities

The Regulatory Manager ensures 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 involves compiling, reviewing, filing, and maintaining well-organized study binders and regulatory records throughout the trial life cycle.