Job Posting Details


Summary

LOCATION: New York, NY

STATUS: Regular, Full-Time

REPORTS TO: Executive Director/Head of Clinical Operations & Project Management

SUMMARY: The Senior CRA will be responsible for working with the study project manager and operations to develop study processes and procedures. The Senior CRA will act as a key contact for CROs and vendors to address study issues and support the successful execution of clinical trials.

Essential Duties and Responsibilities

  • Responsible for the implementation execution of clinical trials at all stages including start-up, enrollment, maintenance, close-down.
  • Oversee global clinical research organizations (CROs) and vendors to ensure study is executed per protocol and within timelines by monitoring all vendor activities.
  • Oversee in-house clinical research associates, as necessary.
  • Coordinate investigator meetings and CRO trainings and develop necessary training materials. Present information and lead round-table discussions, as necessary.
  • Track and monitor day to day study related activities such as patient enrollment, data entry, protocol deviations, and other study matrixes. Flag potential issues for the clinical study manager and work with clinical team to resolve issues.
  • Work with the Executive Director and/or SVP to provide regular and accurate updates regarding the study status.
  • Draft study documents such as informed consents, site correspondence, source documents, newsletters and study manuals.
  • Oversee regional monitor activities in relation to the trial. Review monitoring reports and ensure resolution of any issues raised.
  • Coordinate clinical date review with the data manager. Participate in the database cleaning process, issue data queries, and confirm responses.
  • Review of study required regulatory documents and confirm sites meet all qualifications to enroll patients.

Requirements

  • 5-7+ years in-house clinical experience, including 2+ years directly managing global clinical trials.
  • Thorough understanding of ICH-GCP guidelines and their implementation in clinical trials.
  • University degree (equal to 4 years of college) in (para-) medical, pharmaceutical, sciences, life-sciences or biosciences. Equally recognized degree and/or relevant experience may also be considered.
  • Strong organizational and communication skills are a must for this position.
  • The ability to handle multiple priorities within matrix environment is required.
  • Must possess the ability to work independently and be flexible.
  • Good problem-solving skills are desirable as well as ability to make suggestions to improve efficiencies.
  • Fluent in English (written and spoken). Any other language is an asset.
  • Good computer skills: Word, Excel, PowerPoint, Outlook.
  • May require occasional travel.

Content composed with the free online HTML editor toolkit. Please subscribe for a membership to stop adding links to the edited documents.




Apply for this position Email this job to a friend