6 дней назад
Clinical Trial Specialist (MedTech)
92 000 - 148 350$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Clinical Trial Specialist (MedTech): Managing clinical trial site execution for medical device studies with an accent on protocol compliance, site monitoring, data quality, and regulatory readiness. Focus on implementing risk-based monitoring, resolving site issues, coordinating investigators and CRAs, and ensuring accurate reporting of adverse events and trial documentation.
Location: Full onsite schedule, 5 days per week, in Cincinnati, Ohio or Santa Clara, California, United States. Up to 40% mostly domestic travel is required.
Salary: $92,000–$148,350 annually; Bay Area range: $106,000–$170,200 annually.
Company
Johnson & Johnson MedTech develops healthcare technologies and generates clinical evidence to support the safety, effectiveness, and usability of medical devices.
What you will do
- Act as the primary local company contact for assigned clinical trial sites.
- Support site feasibility, start-up, initiation, monitoring, management, and close-out activities.
- Implement risk-based monitoring and resolve issues with trial sites and clinical research partners.
- Ensure site staff training, timely data entry, query resolution, and complete trial documentation.
- Verify accurate reporting of adverse events, serious adverse events, product quality complaints, and source data.
- Oversee investigational device and trial material accountability, site costs, CAPA actions, and inspection readiness.
Requirements
- Bachelor’s degree required, preferably in life science, physical science, nursing, or biological science.
- 3+ years of clinical trial experience required; candidates with an MS need at least 2 years, and candidates with a PhD need at least 1 year of related experience.
- Previous clinical research experience and knowledge of clinical research processes, trends, and global clinical trial regulations required.
- Ability and willingness to travel up to 40%, mostly domestically.
- Experience with Microsoft Office and company clinical systems, plus strong organizational, presentation, influencing, and problem-solving skills.
Nice to have
- Medical device monitoring experience and knowledge of medical device or combination-product regulations.
- Clinical or medical background.
- CCRA, RAC, CDE, or another relevant industry certification.
Culture & Benefits
- Inclusive work environment guided by the company’s Credo.
- Eligibility for pension and 401(k) savings plans.
- Vacation, sick time, holiday pay, personal and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.
- Regular team meetings, training, process improvement, and subject matter expert opportunities.
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