Lead Clinical Research Associate
USFull-TimeLead
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 4+ years of clinical site monitoring experience
- Required Skills
- LeadershipGCPMentoring
Requirements
- Degree in Life Sciences or related field (MD, PharmD, RN, MSc, or equivalent).
- Minimum of 4+ years of clinical site monitoring experience.
- Experience in global Phase II and/or Phase III trials.
- Prior experience in a Lead CRA, Senior CRA, or equivalent oversight role.
- Solid understanding of GCP and clinical trial regulations.
- Strong leadership, mentoring, and communication skills.
- Proficiency in MS Office and clinical tracking systems.
- Full professional proficiency in English.
- Willingness to travel as required.
Responsibilities
- Oversee clinical trial progress including timelines, enrollment, data cleaning, and compliance.
- Review monitoring visit reports and ensure consistency, accuracy, and adherence to reporting standards.
- Act as a central communication link between monitors, site management associates, and project leads.
- Lead country-level project team meetings and provide status updates to leadership.
- Supervise source data verification and manage study risks and deviations.
- Ensure proper handling of investigational products and clinical supplies.
- Oversee TMF/ISF reconciliation and documentation compliance.
- Support audit preparation and oversee CAPA development.
- Mentor and train clinical monitors, including onboarding.
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