Responsible for the monitoring and oversight of clinical trial sites conducting cell therapy clinical studies in compliance with protocol, ICH-GCP, applicable regulatory requirements, and company SOPs.
Ensure site qualification, initiation, routine monitoring, and close-out visits are performed in accordance with monitoring plans and study timelines.
Verify informed consent process and documentation for all study participants.
Conduct source data verification (SDV) and source data review (SDR) to ensure data accuracy and completeness.
Review and resolve data queries in collaboration with sites and data management.
Monitor chain of identity (COI) and chain of custody (COC) processes related to cell collection, manufacturing, shipping, and administration.
Ensure timely and accurate reporting of adverse events (AEs, SAEs), and special safety events per protocol and regulatory requirements.
Support inspection readiness activities and participate in regulatory inspections or audits as needed.
Serve as the primary point of contact for assigned clinical trial sites.

Requirements

Bachelor’s degree in life sciences, nursing, or a related field required; advanced degree preferred.
Minimum of 3+ years of clinical monitoring experience as a CRA in biotech, pharma, or CRO environments.
Prior experience monitoring cell therapy, gene therapy, immunology, or other complex therapeutic areas strongly preferred.
Strong knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements.
Experience with EDC systems, CTMS, eTMF, and safety reporting processes.
Familiarity with risk-based monitoring approaches.
Prior inspection or audit support experience.
Familiarity with decentralized or hybrid trial models.
Exceptional attention to detail and organizational skills.
Strong written and verbal communication skills.
Ability to manage multiple sites and priorities independently.

Benefits

Eligible for bonus
Benefits
Participation in Company’s stock option plan

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical monitoringsource data verificationsource data reviewadverse event reportingrisk-based monitoringcell therapy monitoringgene therapy monitoringimmunology monitoringregulatory compliancedata accuracy

Soft skills

attention to detailorganizational skillswritten communicationverbal communicationindependent managementcollaborationproblem-solvinginspection readinesstime managementprioritization