Regulatory Affairs Coordinator

4 weeks ago


Charleston, West Virginia, United States Lifelancer Full time

Job Title: Regulatory Affairs Coordinator - Cancer Research Specialist

This is an exciting opportunity for a skilled Regulatory Affairs Coordinator to join our team at Lifelancer. The successful candidate will play a key role in ensuring compliance with regulatory requirements and protecting the safety and well-being of research participants.

The position involves delivering exceptional Institutional Review Board (IRB) and related regulatory support to Principal Investigators and research teams, ensuring adherence to protocols, regulatory compliance, and protection of participant safety and welfare. Additionally, you will be responsible for monitoring study activities, maintaining audit-ready regulatory files, and utilizing electronic research systems/databases to ensure timely submissions and compliance with multiple IRBs and related regulatory entities.

We are seeking a highly organized, detail-oriented, and experienced professional with a strong understanding of medical terminology, clinical research, and regulatory management principles. If you have experience working in oncology standard care practice or research protocols, and are proficient in using computer applications such as Microsoft Word, Excel, and online databases, we would like to hear from you.

In this role, you will have the opportunity to work in a fast-paced environment, adapt to changing client status, regulations, and work environment, and contribute to the success of our research studies. You will also receive comprehensive training and development opportunities to enhance your skills and knowledge.

Key Responsibilities:

  • Deliver exceptional IRB and related regulatory support to PI's and research teams.
  • Maintain audit-ready regulatory files and upload approved protocols, informed consents, and PRMC approvals in OnCore.
  • Monitor study activities to ensure all requisite regulatory approvals are on file prior to research participant consent/enrollment.
  • Proficient utilization of electronic research systems/databases for timely submissions and compliance with multiple IRBs and related entities.

Benefits:

  • New Employees (0-3 Years of Service) start with 28 days of paid leave per calendar year** plus federal and state holidays.
  • Leave plans built to promote a healthy work/life balance with the ability to carry leave forward to a following calendar year; parental leave for childbearing, caregiving, adoption, surrogacy, or foster care; caregiver leave for dependent immediate family members, community service leave for volunteer work, community participation, etc.
  • Tuition Benefit for continuing education and professional development, up to six credit hours per academic semester.
  • Competitive Health Care Plan & FSA option through PayFlex.
  • Tax-deferred annuity retirement savings program with Cash Match Plan.

About Us:

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT, connecting talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. We strive to create a diverse, inclusive environment where employees can grow and thrive. Our mission is to reduce the state cancer burden for all Virginians by addressing biological, social, and policy drivers through high-impact, cutting-edge research; person-centered care across the continuum, from prevention through survivorship; community integration; and training the next generation of community-centric researchers and healthcare professionals.



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