Job Description
Join BioPharm Innovations, a leader in cutting-edge therapeutics, as we revolutionize patient care through groundbreaking clinical trials. As a Senior Clinical Research Associate, you'll drive the execution of pivotal studies while ensuring regulatory excellence and data integrity. Our collaborative environment offers competitive benefits, continuous learning opportunities, and the chance to impact lives globally. What you'll achieve: Lead site management, mentor junior staff, and contribute to protocol development in a culture that values innovation and patient safety.
Responsibilities
- Oversee clinical trial execution at multiple sites, ensuring adherence to GCP and FDA regulations
- Conduct site initiation, monitoring, and closeout visits with meticulous attention to detail
- Manage clinical documentation, source data verification, and regulatory submissions
- Collaborate with cross-functional teams (medical, regulatory, data management) to resolve trial issues
- Mentor junior CRAs and contribute to process improvement initiatives
- Analyze trial data and prepare comprehensive site performance reports
- Represent company at investigator meetings and regulatory audits
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ in CRA roles
- Certified Clinical Research Associate (CCRA) certification required
- Proven expertise in oncology or rare disease trials preferred
- Exceptional knowledge of ICH-GCP, FDA regulations, and EMA guidelines
- Strong analytical skills with experience in EDC systems (e.g., Medidata Rave)
- Excellent communication abilities for stakeholder management
- Ability to travel up to 40% domestically