Job Description
Join BioPharm Solutions Inc., a leader in innovative pharmaceutical research, as a Clinical Research Associate. Based in Newark, NJ, you'll play a pivotal role in advancing groundbreaking treatments while ensuring compliance with FDA and GCP standards. We offer a dynamic environment where your expertise directly impacts patient outcomes and regulatory compliance.
Responsibilities
- Monitor clinical trials at investigational sites to ensure protocol adherence and data integrity
- Conduct site visits for source data verification and regulatory compliance audits
- Collaborate with cross-functional teams to develop study protocols and CRFs
- Manage site relationships and resolve operational challenges proactively
- Prepare and submit regulatory documentation to FDA and ethics committees
- Analyze clinical data and prepare comprehensive study reports
Qualifications
- Bachelor's degree in Pharmacy, Nursing, or Life Sciences (Master's preferred)
- 2+ years of clinical research experience with GCP/FDA compliance
- Certified Clinical Research Associate (CCRA) certification required
- Strong knowledge of ICH-GCP and 21 CFR regulations
- Excellent communication and problem-solving skills
- Ability to travel up to 30% for site visits and conferences