Regulatory Coordinator - 241564 Job at Medix™, Glendale, CA

VDdRRGVuSmVFQmc5TmhSV25xVElCeGFndnc9PQ==
  • Medix™
  • Glendale, CA

Job Description

Regulatory Coordinator

Location: Glendale, CA

Pay: $35 - $50/hour

Position Summary:

The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials. This role ensures adherence to local, state, and federal regulations, including but not limited to FDA, ICH, and GCP guidelines, and supports the smooth conduct of clinical research studies at the site. The coordinator supports clinical research teams by facilitating study start-up approvals and maintaining documentation of regulatory compliance throughout the study duration for research involving human subjects. This role also serves as a central regulatory resource for clinical research staff and reports to the

Director of Research Services.

Essential Functions:

Regulatory Document Management

  • Prepare, review, and submit regulatory documents for IRB submissions, amendments, continuing reviews, and protocol deviations.
  • Review informed consent forms for institutional language; coordinate with legal teams and sponsors to align language with Clinical Trial Agreements (CTAs).
  • Maintain complete and up-to-date regulatory binders, including signed investigator agreements, CVs, and medical licenses.
  • Develop and manage electronic regulatory files per institutional and sponsor standards.
  • Track protocol approvals, renewals, and amendments to ensure regulatory compliance.

Compliance and Reporting

  • Monitor study compliance with federal regulations (FDA, OHRP) and international guidelines (ICH, GCP).
  • Maintain site readiness for audits and inspections; prepare and organize regulatory files and documentation.
  • Support audit response efforts and assist in implementing corrective actions.
  • Report adverse events (AEs), serious adverse events (SAEs), and protocol deviations promptly and accurately. Provide updates to the Director of Research Services.

Communication and Coordination

  • Serve as the primary point of contact with regulatory agencies, sponsors, and IRBs for submissions and status updates.
  • Collaborate with Principal Investigators, study coordinators, and research staff to ensure timely documentation.
  • Facilitate communication with sponsors, CROs, and regulatory bodies.
  • Participate in study start-up meetings, site initiation visits, and monitoring visits as required.

Training and Compliance Support

  • Train research staff on evolving regulatory requirements.
  • Develop and distribute regulatory training materials.
  • Ensure informed consent documents are current and accurately reflect protocol amendments.

Study Start-Up and Maintenance

  • Coordinate with study teams to obtain essential regulatory documents before study initiation.
  • Monitor and document enrollment progress and compliance with study protocols.
  • Assist with close-out procedures, including archiving and final report submission.

Qualifications:

  • Bachelor’s degree required (or equivalent experience).
  • Minimum of 2 years of experience in regulatory coordination within clinical research, preferably in oncology.
  • Knowledge of FDA regulations, ICH guidelines, and GCP standards.
  • Experience with IRB submissions, central IRBs, and regulatory document management.
  • Proficiency in Microsoft Office Suite and electronic regulatory systems.
  • Strong organizational skills and attention to detail with the ability to manage multiple priorities.
  • Preferred: experience in team leadership, initiating new processes, or previous line management responsibilities.
  • Excellent verbal and written communication skills.
  • Certification as a Clinical Research Professional (e.g., ACRP, SOCRA) is not required but is a plus.

Job Tags

Local area,

Similar Jobs

SISL Global

Computer Repair Technician Job at SISL Global

Key Responsibilities: Repair of Laptops and Desktops. Diagnose and resolve advanced technical issues Install, configure, and maintain operating systems, software applications, and system updates. Perform root cause analysis to identify recurring technical... 

Leprino

SQL Web Developer Job at Leprino

 ...This position has an annual target bonus of 5% . Support web development, databases, infrastructure, MES, PLC, and HMI, to ensure...  ...At Least (Required Qualifications): Bachelor's degree in Engineering or technical discipline; or the equivalent relavant work experience... 

PrismHR

Heavy Equipment Operator Job at PrismHR

 ...Job Title: Equipment Operator / Bulldozer Operator Location: Cypress, TX Salary: $250 per day Employment Type: Full-time (Monday...  ...team. The ideal candidate will have experience in operating heavy machinery, specifically bulldozers, and will be responsible for... 

Maxicare Select - Miami, FL

Certified Nursing Assistant (CNA) - Home Health Agency Job at Maxicare Select - Miami, FL

 ...Select, Inc. is a privately-owned and operated home health care agency. We are proud to be serving the South Florida area with quality...  ...including nights and/or weekends* Supportive and compassionate* CNA license or HHA certificate* Take pride in providing high... 

Test Talents Solutions

Human Resources Intern Job at Test Talents Solutions

 ...TEST TALENTS SOLUTIONS is seeking an enthusiastic and motivated HR Intern. Reporting to the Manager of Human Resources, this exciting opportunity provides hands-on experience in a dynamic and collaborative environment. The HR Intern will support various HR functions, contributing...