Senior Clinical Research Associate

3 weeks ago

Miami, Florida, United States Corbus Pharmaceuticals Inc Full time
Job Description

Corbus Pharmaceuticals Inc is seeking a highly skilled Senior Clinical Research Associate to join our team. The ideal candidate will have a thorough knowledge of clinical trial processes, familiarity with electronic systems, and excellent communication skills.

Key Responsibilities:

  • Responsible for all aspects of study site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaison with vendors.
  • Medical record source documentation verification against case report form data, including informing site staff of any errors, ensuring good documentation practices, and communicating protocol deviations appropriately.
  • Conduct qualification, initiation, monitoring, and closeout visits at research sites.
  • Liaise between sites and sponsor for study, site, and subject-related questions, enhance protocol compliance, data entry, and query resolution.
  • Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
  • Verification that the investigator is enrolling only eligible subjects.
  • Performs critical review of clinical trial-related regulatory, investigator site source, and other documents.
  • Ensures assigned investigator sites maintain accurate and complete investigational product/drug accountability and adequate inventory.
  • Verification and review of adverse events, serious adverse events, concomitant medications, and medical history to confirm accurate data reporting in accordance with the protocol.
  • Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended actions to secure compliance.
  • Participate in and follow-up on Quality Assurance visits when requested.
  • Monitor site performance and subject recruitment/retention success, offering suggestions for improvement and implementing action plans in conjunction with the Sponsor.
  • Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable.

Requirements:

  • Minimum of 4-5 years of clinical monitoring or relevant clinical trial experience managing clinical sites.
  • Experience of working in early phase clinical studies and with a small Biotech.
  • Must maintain a valid driver's license and the ability to attend monitoring sites.
  • Strong communication and presentation skills.
  • Must be detail-oriented and efficient in time management.
  • Working knowledge and experience with clinical systems (i.e., Electronic Data Capture (EDC) systems, TMF, and CTMS).
  • Thorough knowledge of ICH-GCP guidelines, human subject protection (HSP), and patient privacy requirements, clinical trial monitoring, Serious Adverse Event (SAE) reporting, and/or regulatory compliance.

About Corbus:

Corbus is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways.

Our pipeline is comprised of two experimental drugs targeting solid tumors: CRB-701, a next-generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFß expressed on cancer cells.

The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 (CB1) receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts.

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