Job Description
Join BioPharm Innovations as a Senior Clinical Research Associate and lead groundbreaking clinical trials that transform patient outcomes. We're pioneering next-generation therapies in oncology and rare diseases, and we need your expertise to ensure regulatory compliance, data integrity, and operational excellence. This role offers mentorship opportunities, cutting-edge resources, and the chance to impact global healthcare standards.
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials in compliance with FDA/ICH-GCP guidelines
- Manage site relationships, conduct site initiation visits, and provide ongoing training to investigative teams
- Oversee data collection, CRF review, and database lock processes with 99% accuracy
- Prepare regulatory submissions (IND/CTA), ethics committee documentation, and safety reports
- Lead cross-functional teams in protocol development, risk assessment, and trial optimization
- Conduct internal audits and ensure corrective/preventive actions are implemented
- Mentor junior associates and contribute to SOP development and process improvements
Qualifications
- Master's degree in life sciences, pharmacy, or related field (PhD preferred)
- 5+ years of clinical research experience with 2+ years in a senior role
- Certification as a CRA (ACRP/SoCRA) and/or regulatory affairs certification (RAC)
- Proven track record in oncology or rare disease trials
- Expertise in EDC systems (e.g., Medidata Rave) and risk-based monitoring
- Strong knowledge of 21 CFR Part 312, ICH-GCP, and FDA guidance documents
- Exceptional problem-solving skills with demonstrated experience in trial startup and closure