Job Description
At PulsePharma Solutions, we are at the forefront of transforming patient care through innovative clinical research. We are seeking a highly motivated Senior Clinical Research Associate to join our dynamic team in Boston, Massachusetts. In this pivotal role, you will ensure the integrity of our clinical trials while facilitating the development of life-saving therapies. We offer a competitive benefits package, including comprehensive health coverage, a 401(k) matching plan, and continuous professional development opportunities.
Responsibilities
- Monitor and supervise clinical trials at assigned sites to ensure strict compliance with Good Clinical Practice (GCP) and study protocols.
- Conduct comprehensive site initiation visits, monitor visits, and closeout activities to ensure trial milestones are met.
- Ensure the accurate collection of clinical data and timely reporting to the Sponsor, Regulatory Affairs, and Ethics Committees.
- Resolve clinical and operational issues with Site Investigators and study staff to maintain trial momentum and patient safety.
- Maintain comprehensive documentation and adhere to local and international regulatory standards, including FDA and EMA guidelines.
- Collaborate with Data Management and Biostatistics teams to address data queries and ensure data integrity.
Qualifications
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field; Master’s degree is highly preferred.
- Minimum of 3-5 years of progressive experience as a Clinical Research Associate or in a similar clinical operations role.
- Current RAC (Registered Clinical Research Associate) certification or willingness to obtain within 12 months.
- Thorough knowledge of ICH-GCP guidelines, FDA 21 CFR Part 11, and local regulatory requirements.
- Excellent verbal and written communication skills, with the ability to negotiate effectively with medical professionals.
- Willingness to travel up to 60% within the region to conduct site visits.