Job Description
<p>Are you a seasoned Clinical Research Coordinator eager to make a profound impact on medical advancements? Apex Medical Research Institute, a leading innovator in cutting-edge healthcare solutions, is seeking a highly motivated and experienced Senior Clinical Research Coordinator to join our dynamic team in Boston, MA. This is an unparalleled opportunity to work on groundbreaking studies that will redefine patient care.</p><p>At Apex, we believe in fostering a collaborative environment where passion meets purpose. You'll be instrumental in managing complex clinical trials from initiation to close-out, ensuring meticulous adherence to protocols, regulatory guidelines, and ethical standards. If you thrive in a fast-paced setting and are committed to scientific integrity and patient safety, we invite you to contribute your expertise to a team dedicated to transforming lives.</p>
Responsibilities
- <ul><li>Lead and manage all aspects of assigned clinical trials, ensuring compliance with ICH-GCP guidelines, IRB regulations, and institutional policies.</li><li>Develop and maintain comprehensive source documents, case report forms (CRFs), and regulatory binders.</li><li>Coordinate patient recruitment, screening, consent processes, and scheduling of study visits, ensuring a positive participant experience.</li><li>Perform accurate and timely data collection, entry, and query resolution, maintaining data integrity.</li><li>Monitor adverse events, serious adverse events, and protocol deviations, ensuring prompt reporting to relevant parties.</li><li>Serve as a primary liaison between investigators, sponsors, CROs, and study participants.</li><li>Assist in the preparation for and participate in internal and external audits and monitoring visits.</li><li>Provide mentorship and guidance to junior research staff, fostering a culture of excellence.</li></ul>
Qualifications
- <ul><li>Bachelor's degree in a health-related field (e.g., Nursing, Biology, Public Health) required; Master's degree preferred.</li><li>Minimum of 4-5 years of direct experience as a Clinical Research Coordinator, with demonstrated leadership experience.</li><li>Strong knowledge of ICH-GCP guidelines, FDA regulations, and human subject protection.</li><li>Certification (e.g., CCRP, CCRC) highly preferred.</li><li>Proficiency with Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS).</li><li>Exceptional organizational skills, attention to detail, and ability to manage multiple complex projects simultaneously.</li><li>Excellent interpersonal, written, and verbal communication skills.</li><li>Ability to work independently and collaboratively in a fast-paced research environment.</li></ul>