Independently monitoring Phase II-III CNS and Cardiovascular clinical trials to ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements.
Conducting site initiation, routine monitoring, and closeout visits while maintaining high-quality oversight of investigative sites.
Performing source data review (SDR), source data verification (SDV), and case report form (CRF) review to ensure accurate and inspection-ready study data.
Building strong partnerships with investigative sites to support enrollment goals, protocol adherence, and overall study success.
Collaborating directly with sponsors, study teams, and site personnel while providing regular updates on site performance and trial progress. Qualifications for the Senior Clinical Research Associate include:
1+ years of Clinical Research Associate experience, including significant experience independently monitoring CNS and/or Cardiovascular clinical trials.
Strong knowledge of ICH-GCP guidelines, FDA regulations, clinical trial operations, and site management best practices.
Experience supporting Phase II and Phase III studies with responsibility for site oversight, monitoring, and issue resolution.
Proven ability to conduct site initiation, interim monitoring, and closeout visits independently.
Strong sponsor-facing communication skills and experience working directly with biotechnology or pharmaceutical clients.
Ability to manage multiple investigative sites, prioritize competing demands, and work effectively with minimal supervision.
Must be located within reasonable distance of a major airport and willing to travel regionally as required. Compensation for the Senior Clinical Research Associate includes:
Salary range: $100,000 - $115,000
Comprehensive benefits package including Medical, Dental, Vision, 401k, PTO, holidays, and sick leave as required by law.

Keywords:

Senior Clinical Research Associate, Senior CRA, Clinical Research Associate, CNS Clinical Trials, Neurology Trials, Neuroscience Research, Cardiovascular Clinical Trials, Cardiology Studies, Phase II Clinical Trials, Phase III Clinical Trials, Clinical Monitoring, Independent Monitoring, Site Monitoring, Site Management, Clinical Operations, ICH-GCP, FDA Regulations, GCP Compliance, Clinical Trial Management, Source Data Verification, SDV, Source Data Review, SDR, CRF Review, Case Report Forms, Site Initiation Visits, SIV, Interim Monitoring Visits, IMV, Closeout Visits, COV, Investigative Sites, Patient Enrollment, Subject Recruitment, Clinical Development, Site Oversight, Risk Management, Protocol Compliance, Regulatory Compliance, Data Quality, Inspection Readiness, Sponsor-Facing, CRO, Biotechnology, Pharmaceutical Research, Clinical Study Management, Trial Execution, Clinical Research Operations, Monitoring Visits, Neurology, CNS Disorders, Epilepsy, Parkinson's Disease, 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Senior Clinical Research Associate - CNS/Cardiovascular