Job Description
Pinnacle Medical Innovations, a leading-edge research institution dedicated to advancing patient care through groundbreaking clinical trials, is seeking a highly motivated and experienced Senior Clinical Research Coordinator to join our dynamic team in Boston, MA. We are at the forefront of medical discovery, committed to ethical research and scientific excellence.
As a Senior Clinical Research Coordinator, you will play a pivotal role in the successful execution of complex clinical trials, from phase I to IV. You will leverage your expertise to manage all aspects of study coordination, ensuring compliance with protocols, regulatory requirements, and good clinical practice (GCP) guidelines. This is an exceptional opportunity to contribute to life-changing medical advancements and further your career in a supportive, innovative environment.
If you are passionate about clinical research, possess strong organizational skills, and thrive in a collaborative setting, we encourage you to apply and become a vital part of our mission to improve global health outcomes.
Responsibilities
- Coordinate and manage multiple clinical trials across various therapeutic areas, ensuring adherence to study protocols, regulatory requirements, and GCP.
- Oversee participant recruitment, screening, consent, and enrollment processes, maintaining accurate and confidential study records.
- Prepare and submit regulatory documents, including IRB applications, amendments, and annual reviews, to ensure continuous compliance.
- Monitor study progress, resolve data queries, and ensure timely and accurate data entry into electronic data capture (EDC) systems.
- Serve as a primary liaison between investigators, sponsors, CROs, and study participants, facilitating effective communication and problem-solving.
- Manage study budgets, vendor relationships, and resource allocation to optimize trial efficiency and cost-effectiveness.
- Conduct quality control checks on research data and source documentation to ensure accuracy, completeness, and integrity.
- Train and mentor junior research staff, promoting best practices and continuous professional development within the team.
Qualifications
- Bachelor's degree in a life science, health-related field, or nursing; Master's degree preferred.
- Minimum of 4-6 years of experience as a Clinical Research Coordinator, preferably in an academic or pharmaceutical setting.
- Strong understanding of FDA regulations, ICH GCP guidelines, and HIPAA privacy rules.
- Proven ability to manage multiple complex clinical trials simultaneously with exceptional attention to detail.
- Excellent communication, interpersonal, and organizational skills.
- Proficiency with Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and Microsoft Office Suite.
- Certification as a Clinical Research Coordinator (e.g., CCRP, CCRC) is highly desirable.
- Demonstrated problem-solving abilities and a proactive approach to challenges.