Senior Clinical Research Associate – Cell & Gene Therapy

Job Description: • Perform and coordinate all aspects of the clinical monitoring and site management process • Conduct remote and on-site visits to assess protocol and regulatory compliance and managing required documentation • Monitors investigator sites with a risk-based monitoring approach • Ensures data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities • Documents observations in reports and letters in a timely manner using approved business writing standards • Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations • Performs trial close out and retrieval of trial materials • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations Requirements: • Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification • Cell & Gene Therapy experience is REQUIRED • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor for Sr CRA Level I) • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor for Sr CRA Level II) • Valid driver's license where applicable • Knowledge of ICH GCPs, applicable regulations, and procedural documents • Good oral and written communication skills Benefits: • Competitive remuneration • Annual incentive plan bonus • Healthcare • Choice of national medical and dental plans • National vision plan • Health incentive programs • Employee assistance and family support programs • Commuter benefits • Tuition reimbursement • At least 120 hours paid time off (PTO) • 10 paid holidays annually • Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) • Accident and life insurance • Short- and long-term disability • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan • Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount