Job Description
Join BioInnovate Therapeutics, a leader in cutting-edge pharmaceutical research, as we pioneer groundbreaking therapies that transform patient lives. We seek a meticulous Senior Clinical Research Associate to drive excellence in clinical trial execution, ensuring regulatory compliance and data integrity while collaborating with cross-functional teams to accelerate drug development.
As a cornerstone of our clinical operations team, you'll shape the future of medicine through rigorous protocol design, site monitoring, and stakeholder communication. This hybrid role (3 days onsite) offers competitive benefits, continuing education stipends, and the opportunity to impact therapies in oncology, immunology, and rare diseases.
Responsibilities
- Oversee clinical trial conduct at 8-12 investigative sites, ensuring GCP/ICH compliance and protocol adherence
- Conduct comprehensive site initiation, monitoring, and closeout visits with 95%+ audit readiness
- Lead risk-based monitoring strategies and electronic data capture (EDC) system validation
- Mentor junior CRAs and train site personnel on clinical trial procedures and documentation
- Collaborate with biostatisticians on data review, query resolution, and interim analysis support
- Prepare regulatory documents (IB updates, safety reports) and FDA correspondence
- Manage study budgets and vendor relationships for clinical supplies and lab services
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ years in CRA role
- Certified Clinical Research Associate (CCRA) or equivalent certification required
- Expertise in oncology/immunology therapeutic areas and EDC systems (e.g., Medidata Rave)
- Proven track record of leading complex multi-site trials with 0 critical findings
- Advanced knowledge of ICH-GCP, FDA regulations, and international guidelines
- Exceptional communication skills with experience training global investigative sites
- Proficient in risk-based monitoring methodologies and e-source data verification