About the role
FSP Sr CRA (Cell Therapy) role based on the published job description. Key responsibilities and requirements were extracted directly from the posting for quick review.
Life SciencesOnsite
Key Responsibilities
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site process failures and implement corrective/preventive actions to ensure compliance and minimize risks, particularly in complex oncology and CGT studies.
- Ensures data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities.
- Assesses investigational product (IP) handling, storage, and accountability, including considerations for advanced therapies such as cell and gene therapy (e.g., chain of identity/custody where applicable).
- Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
- Maintains regular contact between monitoring visits with investigative sites to ensure protocol adherence, timely data entry, and resolution of previously identified issues.
- Conducts monitoring tasks in accordance with the approved monitoring plan and supports site compliance in complex study environments.
Requirements
- Bachelor's degree in a life sciences related field or equivalent
- Minimum 3–5 years of independent clinical monitoring experience
- Experience in oncology and/or cell and gene therapy studies is required
- Experience managing complex clinical trials (e.g., early phase or advanced therapy studies) is strongly preferred
- In some cases, a combination of education, training, and directly related experience may be considered Knowledge, Skills and Abilities:
- Strong clinical monitoring skills with experience in complex therapeutic areas