About The Position

Join our clinical operations team and help ensure high‑quality execution of early‑phase clinical studies. As a Clinical Research Coordinator II, you’ll support study planning, oversee daily trial activities, and maintain participant safety while serving as a key point of contact for the Project Manager and site teams. What You’ll Do Lead study start‑up activities, including developing study documents, schedules, and procedure plans. Coordinate daily study conduct, including check‑ins, dosing days, and participant flow. Monitor participant safety, compliance, and wellbeing; escalate issues as needed. Participate in planning meetings and support client visits, calls, and audits. Review protocols, provide site feedback, and distribute final versions. Maintain study master files and ensure documents are ready for eTMF upload. Manage sample shipping schedules and ensure timely dispatch of biological samples. Support monitoring visits, resolve data queries, and assist with source documentation. Contribute to recruitment planning and updating the PM on enrollment progress. Deliver study‑specific training and help mentor junior staff. Verify participant eligibility at screening and pre‑dose. Approve participant stipend payments and handle participant feedback.

Requirements

  • High school diploma or equivalent (degree in life sciences or allied health preferred).
  • 3–4 years of experience in a clinical research environment.
  • Strong knowledge of protocols, ICH‑GCP, and study procedures.
  • Excellent communication, organization, and prioritization skills.

Nice To Haves

  • Experience coordinating people or processes; customer‑service experience helpful.

Responsibilities

  • Lead study start‑up activities, including developing study documents, schedules, and procedure plans.
  • Coordinate daily study conduct, including check‑ins, dosing days, and participant flow.
  • Monitor participant safety, compliance, and wellbeing; escalate issues as needed.
  • Participate in planning meetings and support client visits, calls, and audits.
  • Review protocols, provide site feedback, and distribute final versions.
  • Maintain study master files and ensure documents are ready for eTMF upload.
  • Manage sample shipping schedules and ensure timely dispatch of biological samples.
  • Support monitoring visits, resolve data queries, and assist with source documentation.
  • Contribute to recruitment planning and updating the PM on enrollment progress.
  • Deliver study‑specific training and help mentor junior staff.
  • Verify participant eligibility at screening and pre‑dose.
  • Approve participant stipend payments and handle participant feedback.

Benefits

  • Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
  • 401(K)
  • Paid time off (PTO)
  • Employee recognition awards
  • Multiple ERG’s (employee resource groups)
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