The Temporary Senior Clinical Research Associate will have a thorough knowledge of clinical trial processes, familiarity with the electronic systems utilized for the conduct of the trial, the ability to interact with the cross-functional study team/vendors, as needed, and an understanding of working with a small Biotech. This role is accountable for site management and monitoring responsibilities with a focus on quality execution and ensuring clinical trial participant safety, and protocol and ICH-GCP compliance. 

Primary 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; liaise with vendors; and other duties, as assigned.
• Medical record source documentation verification against case report form data, including informing the site staff of any errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
• 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 the 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.
• Support development of study tools, project plans and training materials for monitoring purposes.
• Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable.

Skill and Requirement:

• 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.

Corbus Culture:

Our passion. Our purpose. At Corbus, it starts at our core.

We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team flexibility and the opportunity to excel in their professional journey. We provide a welcoming space where collaboration, mentorship and diversity are encouraged. We come together, like no other, to elevate each other and focus on what’s best for patients.

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 (“ADC”) 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. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer