Senior Clinical Research Associate

4 weeks ago

Frederick, Maryland, United States Cartesian Therapeutics Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate to join our team at Cartesian Therapeutics. As a key member of our clinical operations team, you will be responsible for monitoring and managing clinical trial activities, ensuring compliance with protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.


Key Responsibilities
  • Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
  • Communicate with medical site staff, including coordinators, clinical research physicians, and their site staff;
  • Verify investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff;
  • Verify medical record and research source documentation against case report form data, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
  • Conduct on-site and virtual/remote monitoring activities with a risk-based monitoring approach to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
  • Verify that the investigator is enrolling only eligible subjects;
  • Review regulatory documents;
  • Manage investigational product/drug accountability and inventory;
  • Verify and review 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 offer suggestions for improvement;
  • Complete 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 5 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.

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