Senior Clinical Research Associate, Field Monitor
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Remote; flexible hours required to accommodate various time zones and site locations. Travel of up to 50–75% is required, including overnight travel.
Annual base pay: $128,000–$136,000 for the national market and $133,000–$140,000 for premium markets including Los Angeles, San Diego, San Francisco, New York City, Chicago, and Boston. The position is also eligible for a discretionary bonus and equity award.
Company
is a commercial-stage biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and treatments for infectious diseases.
What you will do
- Execute site selection, site initiation, routine monitoring, and close-out visits for assigned clinical trial sites.
- Conduct remote, risk-based, and on-site monitoring, including source data verification and investigational product accountability reconciliation.
- Interpret study protocols and provide sites with guidance on eligibility, safety reporting, scientific rationale, and protocol requirements.
- Identify and mitigate site risks using Risk-Based Quality Management principles, review clinical data, resolve complex queries, and address protocol deviations.
- Support study start-up and conduct through eTMF maintenance, training materials, recruitment and retention strategies, specimen logistics, and investigational product supply coordination.
- Prepare for audits and inspections, support CAPA development, and mentor newly hired field and in-house CRAs.
Requirements
- Bachelor’s degree in clinical research, science, or a health-related discipline, or Registered Nurse status with at least 5 years of on-site monitoring experience.
- At least 6 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, or healthcare setting.
- At least 4 years of independent on-site and remote monitoring experience.
- Current valid driver’s license and successful motor vehicle record checks upon hire and annually thereafter.
- Advanced knowledge of drug development, medical terminology, ICH-GCP E6(R3), and the Code of Federal Regulations.
- High proficiency with EDC, eTMF, CTMS, Microsoft Office, and Adobe, plus strong written, oral, and presentation skills in English.
Culture & Benefits
- Collaborative environment with opportunities to work across different areas of the company.
- Professional development opportunities within a growing publicly traded biopharmaceutical company.
- Medical, dental, and vision plan options, health and financial wellness programs, and an employee assistance program.
- Life, disability, flexible spending, 401(k) with company match, and 529 education savings benefits.
- Paid time off, including holidays, with unlimited PTO for exempt employees.
- Remote work arrangement with flexible hours and eligibility for additional rewards, discounts, legal services, identity theft protection, and pet insurance.
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