Senior Clinical Research Associate (Contractor)

Job Description

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.

This role will support the Miami, FL market and the candidates will need to be based in the greater Miami area.

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.