Regulatory Specialist

Job Title: Regulatory Specialist / Credentialing CoordinatorJob Description The Regulatory Specialist / Credentialing Coordinator maintains regulatory compliance and oversees investigator and staff credentialing activities for a clinical research site. This role ensures that all regulatory documents, study files, licenses, certifications, and training records remain accurate, complete, and audit-ready in accordance with FDA regulations, ICH-GCP guidelines, sponsor requirements, and site standard operating procedures. The position supports the full lifecycle of clinical trials, from study start-up through close-out, by managing regulatory submissions, documentation, and credentialing processes with a high level of organization and attention to detail. Responsibilities Maintain and organize regulatory binders and electronic regulatory files for clinical trials, ensuring consistent structure and accessibility. Prepare, submit, and track regulatory documents to sponsors, contract research organizations (CROs), and institutional review boards (IRBs). Ensure all study documentation is complete, current, and audit-ready at all times. Maintain investigator site files (ISFs) and essential documents throughout the entire study lifecycle. Track IRB approvals, renewals, amendments, safety reports, and continuing reviews to ensure timely compliance. Assist with study start-up activities, including collection, preparation, and submission of required regulatory documents. Support sponsor monitoring visits, audits, and regulatory inspections by providing organized and accurate documentation. Ensure ongoing compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and site standard operating procedures. Maintain study logs, delegation logs, training records, and regulatory tracking systems to support accurate oversight and reporting. Manage credentialing and onboarding activities for Principal Investigators, Sub-Investigators, and research staff. Track and maintain current records of professional licenses, certifications, DEA registrations, medical board certifications, and curriculum vitae (CV) updates for all relevant personnel. Essential Skills 3+ years of clinical research regulatory experience preferred, with direct involvement in regulatory operations for clinical trials. Experience working in a clinical research site environment preferred. Knowledge of FDA regulations related to clinical research. Knowledge of ICH-GCP guidelines and human subject protection requirements. Experience with IRB submissions and regulatory document management. Strong organizational skills and the ability to manage multiple studies and deadlines simultaneously. High attention to detail and accuracy in documentation and record keeping. Bilingual communication skills, with the ability to interact effectively in two languages. Experience working with regulatory submission processes and regulatory tracking systems. Familiarity with clinical research and clinical trial operations. Additional Skills & Qualifications Experience coordinating credentialing activities for investigators and research staff. Ability to collaborate effectively with sponsors, CROs, IRBs, and internal study teams. Strong written and verbal communication skills to prepare, submit, and track regulatory documentation. Comfort working with electronic regulatory systems and maintaining both paper and electronic files. Ability to support audits, monitoring visits, and inspections through organized documentation and professional interaction. Work Environment The role is based in an office environment within a clinical research setting. The Regulatory Specialist / Credentialing Coordinator works on-site with access to both paper and electronic regulatory files, regulatory tracking systems, and clinical trial documentation. The position involves frequent interaction with investigators, research staff, sponsors, CROs, and IRBs, and requires focused, detail-oriented work at a computer and within organized file systems. Job Type & Location This is a Contract to Hire position based out of Hialeah, FL. Pay and Benefits The pay range for this position is $30.00 - $36.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Hialeah,FL. Application Deadline This position is anticipated to close on Sep 18, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr