Senior Clinical Research Coordinator

Job Responsibilities: Independently manage a portfolio of EGID studies across multiple funding sources, phases, and methodologies from start‐up through close‐out. Prioritize daily, weekly, and long‐term workload across multiple active studies. Develop and maintain study timelines, milestone trackers, enrollment trackers, and operational workflows. Identify barriers to execution, operational risks, and proactively communicate issues and solutions to the PI and appropriate stakeholders. Serve as the primary operational point of contact for investigators, sponsors, CROs, collaborators, and internal departments. Provide study status updates to the PI and leadership regarding progress, risks, timelines, and resource needs as requested. Prepare and manage all IRB submissions, including initial applications, amendments, continuing reviews, reportable events, deviations, closures, and recruitment materials. Maintain accurate, complete, and inspection‐ready regulatory files and track approvals, expirations, and required submissions. Ensure studies are conducted in compliance with protocol requirements, GCP, institutional policy, and applicable regulations. Participate in sponsor meetings, feasibility assessments, monitor visits, and study start‐up discussions as appropriate. Independently lead participant recruitment through chart review, database screening, outreach, provider networking, and other strategic methods. Work with internal and external resources to design, improve, and execute recruitment plans for rare disease and specialty populations. Conduct eligibility screening and enroll qualified participants efficiently. Obtain informed consent and assent for adult and pediatric participants, including complex and interventional studies involving families and special populations. Build strong participant and family relationships to support retention and long‐term engagement. Coordinate and conduct research visits across outpatient, procedural, laboratory, and remote settings. Manage all visit logistics with participants and relevant departments, including scheduling, room readiness, supplies, protocol procedures, and required resources. Prepare visit packets, worksheets, CRFs, questionnaires, specimen kits, and source documents. Ensure protocol windows, follow‐up schedules, and visit requirements are met. Collect, organize, and maintain complete source documentation for PI review and signature. Perform accurate and timely data entry in sponsor EDC systems and investigator‐led platforms such as REDCap, Excel, and internal databases. Perform detailed medical record abstraction and clinical data extraction for retrospective and prospective research studies. Coordinate biospecimen collection, processing, tracking, shipment, and documentation in accordance with protocol and institutional requirements. Resolve data queries, reconcile discrepancies, and maintain high data quality standards across all studies. Maintain study tools such as logs, trackers, manuals, source templates, workflows, SOPs, and operational systems to improve execution and consistency. Contribute to the development of research workflows, SOPs, templates, recruitment strategies, and operational systems to support a growing EGID research program. Coordinate with finance, pharmacy, biostatistics, nursing, and administrative teams to ensure deliverables are completed on time. Support audits, monitoring visits, sponsor requests, and internal reviews. Assist with preparation of study reports, abstracts, manuscripts, and presentation materials as needed.

Minimum Qualifications: Bachelor's Degree or equivalent combination of education and experience. Professional certification (ACRP CCRC or SOCRA CCRP) required. Minimum of 4 years relevant clinical experience, including at least one year as a CRC in a CCU setting. Strong knowledge of GCP, federal regulations, IRB processes, and institutional policies. Proficiency in Microsoft Office (Word, Excel, Access, PowerPoint, Outlook) and internet applications. Ability to manage priorities, meet deadlines, and work under pressure. Effective oral, written, and interpersonal communication skills. Commitment to teamwork and problem‐solving in a patient‐focused research environment.

Preferred Qualifications: Master's degree preferred. 7+ years of clinical research coordination experience, preferably in academic medicine, specialty care, pediatrics, gastroenterology, immunology, or rare disease research. Experience independently managing multiple studies simultaneously. Strong knowledge of IRB processes, GCP, informed consent, and human subject protections. Experience with grant‐funded, industry‐sponsored, and investigator‐initiated research. Experience with retrospective, prospective, interventional, translational, and observational study designs. Strong participant‐facing communication skills with pediatric and adult populations. Experience working with medically complex pediatric and/or adult populations preferred. Proficiency in Microsoft Office, especially Excel. Experience with REDCap and electronic data capture systems. Experience working with electronic medical records (Epic preferred). Excellent organizational, problem‐solving, and time‐management skills. Demonstrated ability to work independently while managing multiple competing priorities. Comfort working in a growing program environment where workflows and operational structures continue to evolve. Demonstrated commitment to a long‐term career in clinical research or research operations. NYU Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. Salary range for the role: $70,481.61 – $88,236.75 annually. Actual salaries depend on experience, specialty, education, and hospital need. The listed range does not include bonuses, differential pay, or other compensation or benefits. View Know Your Rights: Workplace discrimination is illegal. To view the Pay Transparency Notice, please click here.