Clinical Research Associate - Gaithersburg, United States - Cartesian Therapeutics

Cartesian Therapeutics
Cartesian Therapeutics
Verified Company
Gaithersburg, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Summary:


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;
  • Onsite and virtual/remote monitoring activities with a riskbased 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;
  • 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 followup 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 fastpaced 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.
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