Clinical Research Associate

4 weeks ago

Reston, Virginia, United States SF Research Institute Full time

Clinical Research Coordinator

We are seeking an experienced Clinical Research Coordinator to oversee clinical trials, testing new drugs and biotechnology. The CRC will be responsible for all aspects of a clinical trial, with an emphasis on study start-up and close-out.

Key Responsibilities:

  • Study Set-up: Develop and approve study-specific documents, source documents, and clinical procedure planning.
  • Coordination: Coordinate critical events during the study period, including IRB submission, FPFV, LPLV, monitoring visits, COV, and DBL. Ensure participant safety, dignity, and compliance, including coordination of medical consultation/treatment as needed.
  • Study Meetings: Facilitate and contribute to key Study Planning meetings, including Clinical Start Up Meeting, Clinical Planning Meeting, and Site Initiation Meeting.
  • Protocol Review: Review protocols, provide consolidated comments from the clinical site on the draft study protocol to the Project Manager or Medical Writer, taking into account logistics, safety, and site capabilities.
  • Clients: Be aware of client expectations for trial conduct and work to meet or exceed them. Facilitate client visits and attend client calls with the assistance of the Project Manager and/or site management where appropriate.
  • Quality: Ensure all protocol deviations and unscheduled events are properly documented and communicated.
  • Recruitment: Work with Recruitment/Screening to define a recruiting plan, ensuring the study is recruited on schedule, and update the respective teams on a regular basis of their recruitment status.
  • Vendor Management: Manage external vendors, consultants, and partners.
  • Liaison: Liaise between clinic staff, project managers, CRAs, and industry sponsors.
  • Financial Management: Oversee all financial aspects, including invoices, receipts, expenses, and accounts payable.
  • CTMS/CRM Management: Manage CTMS/CRM for patient recruitment and visit scheduling.

Awarded Trials/Regulatory Startup Tasks:

  • Complete IRB applications and regulatory documents.
  • Communicate with sponsors/CROs during startup.
  • Negotiate budgets and facilitate signing CTAs.
  • Provide regulatory support during studies and for study closeout.

Requirements:

  • BA degree preferred, can substitute with experience.
  • 3+ years of clinical research experience preferred.
  • Job Type: Full-time.

Annual Base Salary: $65,000-$75,000 (signing-bonus eligible).

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