Senior Clinical Research Associate - Spanish Fluent

September 20

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Thermo Fisher Scientific

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

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Description

• Performs and coordinates all aspects of the clinical monitoring and site management process • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation • Acts as a site processes specialist, ensuring compliance with protocol, ICH-GCP guidelines, and applicable regulations • Documents observations in reports and letters in a timely manner using approved business writing standards • Conducts monitoring tasks in accordance with approved monitoring plan • Ensures trial close out and retrieval of trial materials • Facilitates effective communication between investigative sites, the client company and the PPD project team

Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor) • Valid driver's license where applicable • Effective clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel • Strong attention to detail • Effective organizational and time management skills • Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software

Benefits

• A choice of national medical and dental plans, and a national vision plan • A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA) • Tax-advantaged savings and spending accounts and commuter benefits • Employee assistance program • 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, and volunteer time off in accordance with company policy