Senior Clinical Research Associate - Cell or Gene Therapy

November 27

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Responsible for conducting 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. • Conducts monitoring tasks in accordance with the approved monitoring plan. • Ensures a shared responsibility with other project team members on issues/findings resolution.

Requirements

• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor). • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor). • Considerable clinical research monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) with a demonstrated high level of expertise in all aspects of clinical monitoring. • Valid driver's license where applicable.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs. • Employee assistance and family support programs, including commuter benefits and 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, and short- and long-term disability in accordance with company policy. • 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.

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