Senior Clinical Research Associate (CRA)
New
M
MapLight TherapeuticsBiotech / Clinical Research
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
Requirements
- Approximately 5+ years in the clinical trial industry.
- At least 4 years of clinical monitoring experience including complex therapeutic areas, in-patient trials, and blinded trials.
- Strong working knowledge of Good Clinical Practices (GCPs) and ALCOA+.
- Experience managing multiple Investigator sites and multiple studies simultaneously.
- Experience working in clinical software systems (EDC, CTMS, eTMF, eCOA, EMR).
- Proficiency with Microsoft Office applications.
- Ability to travel independently by air, car, and/or train up to 75%.
- Strong interpersonal, oral, and written communication skills.
- Ability to work independently and proactively.
- CNS and/or neuropsychiatry experience strongly preferred (in-patient schizophrenia or Alzheimer’s disease).
- Experience working in small/emerging biotech is ideal.
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 in accordance with MapLight SOPs, regulatory requirements, and ICH GCP.
- Support the study team in meeting study milestones such as site activation, DSMB meetings, and database lock.
- Perform centralized monitoring activities to ensure timely resolution of action items and oversight of study data quality.
- Maintain quality and compliant documentation including monitoring visit reports, site contact reports, and TMF/ISF maintenance.
- Serve as the main point of contact for Investigator sites to support protocol compliance and training needs.
- Support the study team and Investigator sites during inspections or audits as needed.
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