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Regulatory Affairs Coordinator

2 months ago

Fort Worth, United States Actalent Full time
Regulatory Affairs Coordinator

Job Description:
Looking to hire ahybrid individualwith strong regulatory and clinical researchexperienceto act as aRegulatory Affairs Coordinator IItosupport an ongoingclinical trials . Please note, as the position and study progress, additional job duties will likely be added that are not listed in this description. A candidate must help the site and study wherever needed depending on the specific assignment.

Responsibilities:
  • Conducts study start-up activities and prepares/maintains all regulatory documents
  • Coordinates with the IRB and Sponsors, preparing submissions, answering questions
  • Helps identify and recruit patients and assists with informed consent process
  • Prepares documents and facility for external audits by the sponsor or various regulatory agencies
  • Evaluates protocols with the PI
  • Prepares study invoices and billing, and works with the PI to assist with grant preparation and reporting
  • Performs a variety of other regulatory and coordinator duties as required
Qualifications:
  • Experience as a Regulatory Coordinator or Clinical Research Coordinator, ideally from a hospital/academic setting
  • Experience with electronic medical records (EMR)
  • Experience with electronic data capture (EDC) systems
  • Experience with IRB submittals and other regulatory duties
  • CRC and RAPS certification preferred but not required
Additional Details:
Location: Fort Worth, TX
Duration: 9-month contract to hire
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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com for other accommodation options.