Lead Clinical Research Coordinator - Contract - Bronx, NY
Ready to be the heartbeat of medical research? Join our client as Lead Clinical Research Coordinator and assist in turning innovative science into life-changing care!
探花合集 is working alongside a clinical research site network that enables healthcare practices to operate as high-quality research sites from day one. They conduct Phase II-III clinical trials across multiple therapeutic areas and are currently seeking a Lead Clinical Research Coordinator.
Primary Responsibilities:
The Lead Clinical Research Coordinator (CRC) is a specialized research professional responsible for managing, facilitating, and coordinating daily clinical trial activities. The CRC plays a critical role in ensuring protocol compliance, data integrity, and participant safety from study initiation through completion.
Skills & Requirements:
- Minimum 4-5 years of experience managing multiple Phase II-III industry-sponsored clinical trials as the lead coordinator
- Bachelor's degree required; clinical credential (RN, LPN, MA) or Master's degree a plus
- GCP Certification required; CCRC or CCRP certification strongly preferred
- Demonstrated mastery of ICH/GCP guidelines, FDA regulations, and CFR requirements governing human subject research
- Experience with EDC systems, eSource documentation (Preferably CRIO)
- Proficiency in medical terminology, clinical documentation, and good documentation practices
- Demonstrated problem-solving and strategic decision-making ability; ability to react calmly and effectively in emergent situations
- Strong organizational skills with the ability to independently manage multiple concurrent protocols
- Clear, professional verbal and written communication skills;
- Proficient in Microsoft Office Suite, Google Workspace and clinical research platforms
- Phlebotomy experience a plus
- Fluency in English & Spanish is required
The Lead Clinical Research Coordinator's responsibilities will be:
- Independently conduct and manage assigned clinical trials in accordance with study protocols, GCP/ICH guidelines, FDA regulations, and company SOPs, from site initiation through study close-out
- Implement and coordinate all aspects of assigned trials including start-up activities, vendor management, subject recruitment and retention, source document development, visit scheduling, regulatory document collection, protocol training, EDC data entry, query resolution, amendment implementation, and close-out reporting
- Assist with study operations and workflow optimization to support successful protocol execution.
- Manage, monitor, and report adverse events, serious adverse events (SAEs), and protocol deviations to Sponsors and IRBs with accurate and timely documentation
- Prepare for and lead monitoring visits, audits, and inspections; resolve data queries and protocol issues identified by monitors in a timely and professional manner
- Perform procedures and assessments per protocol, including phlebotomy, ECGs, drug preparation and administration, and lab specimen processing
- Evaluate and screen potential subjects for protocol eligibility; manage informed consent and participant retention activities
- Collaborate with investigators, sponsors, CROs, labs, and internal teams to ensure protocol requirements are fully understood and consistently executed
- Maintain working knowledge of study protocols, lab manuals, equipment calibration, and study supply inventory
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j@cerchio@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - /privacy-policy
.png)
.png)
