Job Description
We are seeking a visionary Senior Clinical Research Associate to lead clinical trials in our Boston hub. You will be responsible for ensuring the scientific validity and regulatory compliance of our global research initiatives. This is an opportunity to work with cutting-edge therapies and a collaborative team of medical experts.
At GlobalPharma Solutions, we prioritize innovation and patient safety. We are looking for a detail-oriented professional who thrives in a fast-paced environment and is committed to advancing healthcare.
Responsibilities
- Oversee the monitoring and execution of clinical trials, ensuring full adherence to GCP and regulatory standards.
- Conduct on-site monitoring visits to assess site performance, data integrity, and patient safety.
- Manage relationships with Principal Investigators (PIs), study coordinators, and CROs.
- Review source documents and electronic data capture (EDC) systems to ensure accurate data reporting.
- Prepare and submit comprehensive trial documentation to regulatory bodies.
- Identify and mitigate risks associated with clinical trial execution.
- Participate in protocol design and study start-up activities.
Qualifications
- Bachelor’s, Master’s, or PharmD degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3-5 years of experience in clinical research, CRO, or pharmaceutical industries.
- Valid GCP certification (e.g., RAC) is highly preferred.
- Deep understanding of FDA regulations, ICH guidelines, and local ethics committee requirements.
- Strong analytical skills with the ability to interpret complex clinical data.
- Excellent verbal and written communication skills for stakeholder management.
- Willingness to travel up to 50% of the time to various trial sites.