Job Description
Join a global leader in pharmaceutical innovation shaping the future of healthcare! BioPharm Innovations Inc. is seeking a dynamic Senior Clinical Research Associate to lead pivotal clinical trials across our oncology portfolio. As a key member of our Clinical Operations team, you'll drive protocol execution, ensure regulatory compliance, and collaborate with cross-functional experts to deliver life-changing therapies to patients worldwide. Our cutting-edge research facilities in Princeton, NJ, offer state-of-the-art laboratories and a collaborative environment where your expertise will directly impact drug development timelines.
We offer a comprehensive benefits package including competitive compensation, flexible work arrangements, tuition reimbursement, and generous paid time off. Join us in accelerating breakthroughs that matter!
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials ensuring adherence to GCP/ICH guidelines and FDA regulations
- Lead site initiation, monitoring, and closeout activities with 15+ global investigative sites
- Collaborate with medical, regulatory, and data teams to resolve protocol deviations and ensure data integrity
- Develop and maintain comprehensive trial documentation including CRFs, informed consent forms, and regulatory submissions
- Conduct risk-based monitoring and vendor management to optimize trial efficiency
- Mentor junior CRAs and contribute to process improvements within the clinical operations framework
- Present trial progress and risk assessments to stakeholders at executive review meetings
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field; Master's/PhD preferred
- Minimum 5 years of clinical research experience with 2+ years in CRA role
- Certification as ACRP or SoCRA CRA with proven track record in oncology trials
- Expert knowledge of FDA 21 CFR Part 312, ICH-GCP, and clinical trial regulations
- Advanced proficiency in CTMS (e.g., Veeva Vault RIM) and EDC systems (e.g., Medidata Rave)
- Exceptional problem-solving skills with ability to navigate complex operational challenges
- Willingness to travel up to 40% for site visits and sponsor meetings