Note: The job is a remote job and is open to candidates in USA. Planet Pharma is a growing clinical organization supporting global clinical trials, and they are seeking experienced Clinical Research Associates to join their team. The role involves managing clinical trial sites and ensuring compliance with guidelines while conducting various site visits and supporting recruitment initiatives.
Responsibilities
- Manage clinical trial sites and serve as the primary point of contact between investigators, site personnel, and sponsors
- Conduct site qualification visits, site initiation visits, interim monitoring visits, close-out visits, and co-monitoring visits
- Perform source data verification (SDV) and source data review (SDR)
- Ensure clinical trials are conducted in compliance with ICH-GCP guidelines, SOPs, and regulatory requirements
- Review informed consent forms, eligibility criteria, protocol compliance, adverse events, and investigational product accountability
- Build strong relationships with Principal Investigators, study coordinators, pharmacists, and site staff
- Support recruitment initiatives and ensure study timelines and deliverables are met
Skills
- Bachelor's degree or equivalent experience in a clinical/life sciences-related field
- Minimum 2+ years of independent clinical monitoring experience
- Experience managing clinical trial sites from initiation through close-out
- Strong knowledge of ICH-GCP guidelines and clinical trial regulations
- Experience with SDV/SDR and site monitoring activities
- Ability to travel approximately 70%
- Oncology, cardiovascular, or ophthalmology trial experience
- Previous CRO experience
- Strong history of successful site monitoring performance
- Ability to provide professional references from clinical trial partners
- French fluency is preferred for candidates supporting Quebec sites
Company Overview
Company H1B Sponsorship