Lead Clinical Research Associate
New
M
MapLight TherapeuticsBiotech drug discovery
Location: RemoteFull-TimeLead
Salary$165,000 — $185,000 USD
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Job Details
- Experience
- 7+ years in the clinical trial industry with at least 5 years of clinical monitoring
- Required Skills
- GCP
Requirements
- Bachelor’s degree in a relevant field or RN.
- Approximately 7+ years in the clinical trial industry.
- At least 5 years of clinical monitoring experience.
- Experience with complex therapeutic areas, in-patient trials, and blinded trials.
- Experience managing a clinical monitoring team at a pharmaceutical, biotech company, or CRO.
- Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations.
- Proficiency with clinical software systems (CTMS, eTMF, RIM).
- Proficiency with Word, Excel, PowerPoint, and Microsoft Office.
- Ability to travel independently by air, car, and/or train (up to 30-40%).
- CNS and/or neuropsychiatry experience, specifically in-patient schizophrenia and Alzheimer’s disease psychosis, strongly preferred.
Responsibilities
- Lead and manage a team of Clinical Research Associates, providing line management, performance management, and career development.
- Maintain site management and monitoring responsibility for at least one site, including conducting pre-study, initiation, interim, and closeout visits.
- Ensure study team compliance with internal procedures and regulatory requirements (GCP).
- Develop and maintain the study monitoring plan, templates, and tools, implementing strategies based on study design and recruitment goals.
- Act as a core member of the cross-functional study team, providing expertise on monitoring processes and participating in risk management.
- Review monitoring visit reports and Key Performance Indicators to ensure quality standards and performance compliance.
- Support site management documentation, including Trial Master File (TMF) and Investigator Site File (ISF) maintenance.
- Support internal and external stakeholders during inspections or audits.
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