Note: The job is a remote job and is open to candidates in USA. Piper Companies is seeking a Senior Clinical Research Associate to support CNS and Cardiovascular Phase II–III clinical studies. The role oversees site performance, ensures regulatory compliance, conducts monitoring visits and data reviews, and supports successful trial execution through sponsor and investigative-site collaboration.
Responsibilities
- 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
Skills
- 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
Benefits
- Medical
- Dental
- Vision
- 401k
- PTO
- Holidays
- Sick leave as required by law
Company Overview
Company H1B Sponsorship