Senior Clinical Research Associate (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Senior Clinical Research Associate (Clinical Research): Overseeing all aspects of clinical monitoring and site management in compliance with GCP and regulatory requirements with an accent on protocol adherence and data integrity. Focus on conducting site visits, managing sponsor relationships, and ensuring inspection-ready patient data.
Location: Remote (US). Must reside in a U.S. state where the company is authorized to hire. Not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.
Company
partners with biopharmaceutical Sponsors to provide end-to-end clinical trial delivery, home health services, and market access consultancy.
What you will do
- Oversee clinical monitoring and site management according to GCP, global regulatory requirements, and SOPs.
- Conduct on-site and remote monitoring visits, including SIVs, routine monitoring, and close-out visits.
- Lead site feasibility activities, evaluate questionnaires, and conduct Site Qualification Visits (SQVs).
- Verify source data and CRFs for completeness, accuracy, and consistency to keep site files audit-ready.
- Manage and resolve data queries, analyze error trends, and implement corrective and preventative actions.
- Build and maintain strong relationships with sponsors and site staff, serving as a key point of contact.
Requirements
- Bachelor’s degree in life sciences, nursing, or a related field.
- 5–7+ years of experience conducting on-site and remote monitoring visits.
- Broad therapeutic exposure across multiple study types and indications.
- Solid understanding of medical terminology and ICH-GCP.
- Proficiency with MS Office and EDC systems.
- Willingness to travel up to 80%.
Nice to have
- Proven ability to train, coach, and mentor clinical research staff.
- Experience developing study-specific monitoring documents such as CMPs and deviation plans.
Culture & Benefits
- Medical, dental, and vision insurance.
- 401K safe harbor plan with company match.
- FSA, HSA, and voluntary critical illness, hospital indemnity, and accident insurance.
- Paid vacation, holiday, sick, and volunteer time.
- Paid maternity and paternity leave.
- Inclusive, supportive environment focusing on integrity, accountability, and respect.
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