Senior Clinical Research Associate (CRA)
New
M
MapLight TherapeuticsBiotech
This is a remote role located in the Texas OR Arizona region.Full-TimeSenior
Salary$145,000 — $160,000 USD
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Job Details
- Experience
- Approximately 5 plus years in the clinical trial industry with at least 4 years of clinical monitoring experience
- Required Skills
- Microsoft Office
Requirements
- Approximately 5 plus years in the clinical trial industry.
- At least 4 years of clinical monitoring experience.
- Experience with complex therapeutic areas, in-patient trials, and blinded trials.
- Experience managing multiple Investigator sites and multiple studies simultaneously.
- Strong working knowledge of Good Clinical Practices (GCPs) and ALCOA+.
- Experience working in clinical software systems (EDC, CTMS, eTMF, eCOA, EMR).
- Proficiency with Microsoft Office applications.
- Willingness to travel nationally, including up to 75% travel.
- Ability to travel independently by air, car, or train.
- Location near a major airport preferred.
Responsibilities
- Effectively manage assigned Investigator sites and maintain positive relationships with site personnel.
- Prepare for and conduct Pre-Study, Initiation, Interim and Closeout monitoring visits.
- Support the study team in meeting study milestones such as site activation and database lock.
- Perform centralized monitoring activities to ensure timely resolution of action items and proactive risk management.
- Maintain quality and compliant documentation including monitoring visit reports and the Trial Master File.
- Serve as the primary point of contact for Investigator sites.
- Support site inspections or audits as needed.
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