Job Description
Join BioGenix Therapeutics, a leader in innovative pharmaceutical research, as a Senior Clinical Research Associate. You'll be pivotal in advancing groundbreaking therapies while working in our state-of-the-art Cambridge facility. This role offers the opportunity to shape the future of medicine through rigorous clinical trials and regulatory compliance. We provide a collaborative environment with competitive benefits and professional growth opportunities.
Responsibilities
- Oversee clinical trial execution across multiple sites ensuring protocol adherence and GCP compliance
- Manage site monitoring activities, including source data verification and vendor oversight
- Lead regulatory submissions and maintain FDA/EMA compliance documentation
- Collaborate with cross-functional teams to resolve protocol deviations and ensure data integrity
- Develop and maintain strong relationships with investigative sites and key opinion leaders
- Analyze clinical data and prepare comprehensive study reports for regulatory review
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ years in CRA or equivalent role
- Certified Clinical Research Associate (CCRA) certification required
- Proven expertise in GCP/ICH guidelines and FDA/EMA regulations
- Exceptional data management and audit documentation skills
- Strong problem-solving abilities and attention to detail
- Excellent communication and stakeholder management skills
- Ability to travel up to 40% domestically