Research Coordinator - Evidence Generation
$65,000–$90,000 year
On-site · Waltham, Massachusetts, United States
Job Summary
Results-oriented Research Coordinator - Evidence Generation to support clinical and translational research in virally driven cancer diagnostics. Coordinate regulatory/IRB submissions, onboarding of collaborators, data management for prospective and retrospective studies, and multi-site coordination across sites including NAVigate-HPV. Collaborate with data scientists, biostatisticians, medical writers, and external partners to ensure timely study delivery, adherence to protocols, data sharing agreements, and compliant publication processes. Strong project management, stakeholder communication, and familiarity with HIPAA, GCP, and regulatory requirements are essential; preferred experience in oncology, molecular diagnostics, real-world data registries, and CRFA/DSA/DTA workflows.
Required Qualifications
- BA/BS or equivalent experience required
- MA/MS or MPH in oncology, epidemiology, public health, or related field strongly preferred
- 3–5 years of clinical research coordination experience
- Experience coordinating multi-site or cross-institutional research collaborations
- Experience facilitating data-sharing (DSA/DTA), material transfer, research, and limited data set use agreements
- Familiarity with GCP guidelines, 21 CFR Part 11, and HIPAA applied to clinical research
- ACRP (CCRC/CCRA), SOCRA (CCRP) certifications strongly positive; CITI training a plus
- Must obtain and maintain GCP certification within 30 days of hire
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