Job Description
Are you ready to shape the future of healthcare? MediCore Solutions is seeking a highly motivated Senior Clinical Research Associate (CRA) to join our elite team in Boston, Massachusetts. In this pivotal role, you will oversee clinical trials, ensuring they meet the highest standards of quality, safety, and compliance.
We are revolutionizing the pharmaceutical landscape with our data-driven approach to clinical research. As a Senior CRA, you will work closely with cross-functional teams and investigators to drive study success from initiation to completion. If you have a passion for medical science and a knack for problem-solving, we want to hear from you.
Why Join Us?
- Competitive compensation package.
- Comprehensive health benefits.
- Flexible work arrangements and remote work options.
Responsibilities
- Monitor ongoing clinical trials to ensure adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements.
- Perform on-site monitoring visits to assess data integrity, patient safety, and study conduct.
- Manage study timelines and identify potential risks or delays early in the process.
- Liaise effectively with investigators, study coordinators, and sponsor representatives to ensure clear communication.
- Prepare and submit regulatory documents, amendments, and annual reports in a timely manner.
- Conduct source data verification (SDV) and ensure accurate data capture in electronic data capture (EDC) systems.
- Participate in project meetings and contribute to the continuous improvement of monitoring processes.
Qualifications
- Bachelor’s degree in Nursing, Life Sciences, Pharmacy, or a related field; Master’s degree preferred.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar clinical research role.
- Current RAC (Registered Clinical Research Associate) certification is highly desirable.
- Strong understanding of ICH-GCP guidelines, FDA regulations, and local regulatory requirements.
- Excellent analytical skills with the ability to interpret complex medical data.
- Exceptional written and verbal communication skills, capable of interacting with diverse stakeholders.
- Proficiency in using EDC systems (e.g., Medidata Rave, Oracle Clinical) and MS Office suite.