Note: The job is a remote job and is open to candidates in USA. Virtue America is seeking an entry-level Clinical Research Associate to support clinical research activities and clinical trial operations in the pharmaceutical and life sciences industry. The role assists with site coordination, study documentation, data review, regulatory compliance, safety tracking, and maintaining trial quality throughout the study lifecycle.
Responsibilities
- Clinical Trial Support: Assist with day-to-day activities associated with clinical research studies and trial operations
- Site Management: Support communication with clinical research sites, investigators, study coordinators, and clinical teams
- Study Documentation: Maintain and organize essential clinical trial documents, study files, reports, and correspondence
- Monitoring Support: Assist with preparation for site initiation, monitoring visits, and close-out activities under appropriate supervision
- Data Review: Review clinical trial documentation and data for completeness, consistency, and compliance with study requirements
- Protocol Compliance: Support adherence to study protocols, procedures, timelines, and applicable clinical research standards
- Regulatory Compliance: Ensure activities follow GCP, FDA regulations , applicable clinical research requirements, and company SOPs
- Issue & Deviation Support: Assist with documenting protocol deviations, action items, site issues, and follow-up activities
- Safety Support: Assist clinical teams with appropriate documentation and tracking of adverse event and safety-related information
- Trial Tracking: Maintain study trackers, enrollment updates, monitoring information, and other clinical trial metrics
- Cross-Functional Collaboration: Work with Clinical Operations, Data Management, Regulatory Affairs, Pharmacovigilance, QA, and other study teams
- Audit Readiness: Maintain accurate and complete trial documentation to support sponsor audits and regulatory inspections
Skills
- Bachelor's or Master's degree in Clinical Research, Life Sciences, Pharmacy, Pharmaceutical Sciences, Biotechnology, Nursing, Biology, Biochemistry , or a related field
- Basic understanding of clinical trials, clinical research processes , and the drug development lifecycle
- Familiarity with GCP, FDA regulations, informed consent, clinical trial protocols , and study documentation
- Basic understanding of clinical trial terminology such as ICH-GCP, CRF/eCRF, adverse events, protocol deviations , and essential documents
- Strong organizational and time-management skills with excellent attention to detail
- Good written and verbal communication skills
- Strong analytical and problem-solving abilities
- Ability to manage documentation and follow standardized procedures accurately
- Fresh graduates and candidates with 0–2 years of relevant experience are encouraged to apply
Benefits
- Full time
- Remote
Company Overview
Company H1B Sponsorship