Contract Lead Clinical Research Associate (Lead CRA), Solid Tumor Oncology Sponsor

Category: Lead CRA
Job #: 10955
Utilization: 100%
Location: US
Job Type: 1099 (Option to Convert to Perm)
Therapeutics: Solid Tumor Oncology, Hema/Oncology, Phase I

Our Sponsor client is adding a Lead CRA to support a solid tumor oncology study, including Phase I work. This is a 1099 contract role at 100% utilization. It is fully remote and based in the US, but you will need to work Eastern Time Zone hours. This is an oversight role: the Lead CRA will not have assigned sites. You will lead and support the monitoring team and work closely with the Project Manager and Associate Clinical Project Manager.

The team plans to start interviews the first week of November.

Job Responsibilities:
  • Lead, coordinate, and support a team of field CRAs across the study, serving as their first point of contact for monitoring questions and escalations
  • Review monitoring visit reports and follow-up letters for quality, accuracy, timeliness, and GCP and protocol compliance
  • Track site performance metrics, including recruitment, enrollment, data entry, query resolution, and protocol deviations, and help sites and CRAs build corrective plans where needed
  • Train CRAs on the protocol, study plans, and study procedures, and roll out training whenever the protocol is amended
  • Mentor CRAs and help with onboarding, workload balance, and consistent monitoring practices across the team
  • Partner with the Project Manager and ACPM on study timelines, resourcing, risks, and status reporting
  • Support data cut and database lock activities by driving CRA and site follow-up on open queries and outstanding data
  • Keep study trackers and the CTMS current, and ensure monitoring documentation is inspection-ready
  • Escalate site quality, safety, and compliance issues to study leadership quickly
  • Serve as a subject matter resource on site management, so CRAs get practical guidance on site relationships, essential documents, and investigational product accountability
Job Qualifications:
  • At least 5 years of experience as a fully dedicated Lead CRA or Clinical Research Manager for a CRO or Pharma company, with that experience held within the past 2 years
  • A field monitoring background with strong site management knowledge
  • At least 2 years of solid tumor oncology experience
  • At least 1 year of Phase I experience
  • A Bachelor’s degree, or a background as a practicing nurse or similar medical professional with equivalent experience
  • COVID-19 vaccination
  • Located in the US and able to work Eastern time zone hours
  • Available at 100% utilization

Nice to Have

  • Phase I oncology experience
  • Hematology/oncology experience
  • Experience leading studies through multiple protocol amendments
  • Location in the Eastern or Central time zone
  • Ability to travel occasionally (travel is rare, and it may include an occasional in-house meeting)
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