Job Description
Join Global Health Innovations at the forefront of medical breakthroughs. We're seeking a passionate Lead Clinical Research Associate to drive pivotal trials that transform patient outcomes. Our state-of-the-art Boston facility offers unparalleled resources to support your career growth while making tangible impacts in healthcare innovation.
As a key member of our multidisciplinary team, you'll collaborate with top-tier physicians, biostatisticians, and regulatory experts to ensure protocol integrity and data excellence. This hybrid role combines on-site coordination with flexible remote options, fostering work-life balance.
Responsibilities
- Oversee clinical trial execution across 3+ sites, ensuring GCP compliance and FDA regulations
- Lead protocol development, site selection, and investigator training initiatives
- Manage electronic data capture systems and conduct real-time data quality checks
- Coordinate with IRBs and regulatory bodies for submissions and audits
- Mentor junior CRAs and optimize clinical trial workflows
- Present trial progress to executive stakeholders and regulatory authorities
Qualifications
- Master's degree in Life Sciences, Nursing, or related clinical field
- 5+ years of clinical research experience with 2+ in lead/supervisory roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced proficiency in Medidata Rave and clinical trial management systems
- Exceptional communication skills for cross-functional collaboration
- Experience managing FDA audits and regulatory submissions