Epicareer Might not Working Properly
Learn More

Regulatory Affairs Coordinator II

Salary undisclosed

Apply on


Original
Simplified
Regulatory Coordinator II - Hybrid Opportunity

Job Description:

Looking to hire an individual with strong regulatory and clinical research experience to act as a Regulatory Coordinator II to support an ongoing clinical 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

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 submissions and other regulatory duties

Additional Details:

Location: Fort Worth, TX

Duration: 9-month contract to hire

  • Please send your resume and 2-3 professional references to hjaquez @actalentservices.com for more information.*

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 [email protected] for other accommodation options.