Job Description
Shape the Future of Medicine
Join a world-class team dedicated to transforming the lives of patients with serious diseases. Vertex Pharmaceuticals is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to oversee our clinical development programs. In this pivotal role, you will ensure the integrity of clinical trials, manage site relationships, and drive the delivery of life-saving therapies.
Why Join Us?
- Work on breakthrough therapies with a high unmet medical need.
- Competitive compensation and comprehensive benefits package.
- Professional development and leadership opportunities.
- Collaborative and inclusive culture.
Responsibilities
- Execute comprehensive clinical trial monitoring plans, including initiation, monitoring visits, and close-out of clinical studies.
- Ensure strict adherence to Good Clinical Practice (GCP) guidelines, ICH regulations, and company Standard Operating Procedures (SOPs).
- Manage relationships with Contract Research Organizations (CROs), investigators, and site staff to ensure project timelines are met.
- Monitor source data and ensure accurate and timely entry of data into Clinical Data Management Systems.
- Track and report Serious Adverse Events (SAEs) and ensure prompt communication with Regulatory Affairs.
- Participate in protocol design, CRF development, and clinical study reports.
Qualifications
- BS/BA degree in a scientific discipline (Biology, Chemistry, Pharmacology) or equivalent combination of education and experience.
- Minimum of 3-5 years of experience in clinical research, monitoring, or related roles within the biopharmaceutical industry.
- Valid Certified Clinical Research Professional (CCRP) or equivalent certification is strongly preferred.
- Strong knowledge of FDA regulations, EMA guidelines, and ICH E6(R2).
- Excellent communication, interpersonal, and organizational skills.
- Ability to travel up to 75% of the time to various clinical sites.