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Clinical Research Associate
4 months ago
We are seeking a highly skilled and experienced Clinical Research Associate (CRA) with a strong background in Phase I-III clinical trials, particularly in the Autoimmune therapeutic area, with desired expertise in Cell & Gene Therapy. The ideal candidate will be responsible for monitoring and managing clinical trial activities, ensuring compliance with protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. This role requires meticulous attention to detail, excellent communication skills, and the ability to work effectively within a multidisciplinary team environment.
Principal Duties/Responsibilities:
* Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
* Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
* Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
* Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
* On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
* Verification that the investigator is enrolling only eligible subjects;
* Regulatory document review;
* Investigational product/drug accountability and inventory;
* Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
* Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and
* Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications:
* Bachelor's degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred.
* Minimum of 6 years of experience as a Clinical Research Associate, with significant experience in Phase I-III clinical trials within the Autoimmune therapeutic area.
* Demonstrated expertise in Cell & Gene Therapy trials is highly desired.
* Strong understanding of GCP, FDA, and ICH guidelines, regulations, and compliance requirements.
* Proven ability to manage multiple tasks, prioritize workload effectively, and meet deadlines in a fast-paced environment.
* Excellent interpersonal, communication, and organizational skills.
* Ability to travel domestically and internationally, as required, up to 50%.
* Certification as a Clinical Research Professional (CCRP) or equivalent is a plus.
* Proficiency in Microsoft Office Suite and familiarity with electronic data capture (EDC) systems.
Work Environment:
The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.
