Clinical Research Associate (Medical)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Clinical Research Associate (Medical): Coordinating all aspects of clinical monitoring and site management for funded clinical trials with an accent on compliance with ICH GCP and FDA guidelines. Focus on performing on-site and remote monitoring visits, verifying patient records, and ensuring audit-ready data.
Location: Remote, Must reside in a U.S. state where the company is authorized to hire (excluding CA, CO, NY, WA, NJ, MA, IL, HI, and DC)
Company
partners with biopharmaceutical sponsors to provide end-to-end clinical trial delivery, home health services, and market access consultancy.
What you will do
- Perform Site Initiation (SIV), Interim (IMV), and Close Out Visits (COV) both on-site and remotely.
- Review and verify patient files, informed consent, and source documents for accuracy and compliance.
- Contribute to the development of protocols, study tools, and site documentation.
- Identify, document, and report site protocol deviations and violations.
- Manage query resolution and review investigational drug accountability.
- Mentor junior team members and assist in the development of Standard Operating Procedures (SOPs).
Requirements
- 1+ years of on-site and remote monitoring experience.
- BA/BS degree, preferably in life science, nursing, pharmacy, or a related field.
- Clinical background and a broad range of therapeutic experience.
- Willingness to travel up to 80%.
- Proficiency in MS Office and experience using EDC systems.
Culture & Benefits
- Comprehensive medical, dental, and vision insurance.
- 401K safe harbor plan with company match.
- FSA and HSA options.
- Paid vacation, holiday, sick, and volunteer time.
- Paid maternity and paternity leave.
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