Senior Clinical Research Associate – Cell & Gene Therapy
Job reputed company:
- reputed company and coordinate reputed company aspects of the clinical monitoring and site management process
- Conduct remote and on-site reputed company 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 reputed company 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 reputed company out and retrieval of trial materials
- Ensures that required essential documents are complete and in reputed company, according to ICH-GCP and applicable regulations
Requirements:
- Bachelor's degree in a life science reputed company field or a Registered Nursing certification or equivalent and relevant formal reputed company/vocational qualification
- Cell & Gene Therapy experience is REQUIRED
- Previous experience that provides the knowledge, skills, and abilities to reputed company 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 reputed company the job (comparable to 3+ years as a clinical research monitor for Sr CRA reputed company)
- Valid reputed company'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
- reputed company
- Choice of national medical and dental plans
- reputed company plan
- Health incentive programs
- Employee assistance and family support programs
- Commuter benefits
- Tuition reimbursement
- At least 120 hours reputed company time off (PTO)
- 10 reputed company holidays annually
- reputed company 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 reputed company to purchase company stock at a discount
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