Senior Clinical Research Coordinator
NYU Grossman School of Medicine is one of the nation's top-ranked medical schools, committed to improving the human condition through medical education, scientific research, and direct patient care. An integral part of NYU Langone Health, the school embraces equity and inclusion as fundamental values.
About the role
The Senior Clinical Research Coordinator (Senior CRC) serves as a senior research coordinator for the Eosinophilic Gastrointestinal Diseases (EGID) Program at NYU, directed by Mirna Chehade, MD, MPH. This role is responsible for the day-to-day execution and coordination of a diverse clinical research portfolio focused exclusively on EGIDs, including industry-sponsored, government-funded, investigator-initiated, foundation-supported, and unfunded studies across multiple designs (retrospective, prospective, survey-based, interventional, translational, and biomarker-based research).
This is a highly autonomous role designed for an experienced coordinator who can manage competing priorities, identify operational challenges, and drive studies forward with a high degree of independence. The Senior CRC must function as the primary coordinator responsible for study operations, ensuring studies remain compliant, organized, and on track from startup through closeout.
Responsibilities
- Independently manage a portfolio of EGID studies across multiple funding sources, phases, and methodologies from startup through closeout.
- 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 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.
- 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 startup discussions.
- 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.
Requirements
- Bachelor's Degree or equivalent combination of education and experience required.
- Professional certification (ACRP CCRC or SOCRA CCRP) required.
- 4 years of relevant clinical experience, with a minimum of one year as a CRC in the CCU.
- Intermediate competency in medical terminology and Good Clinical Practice (GCP) guidelines.
- Familiarity with Federal Regulations governing human subjects research, Institutional Review Board (IRB), and institutional policies and procedures.
- Proficiency in Microsoft Office applications (Word, Excel, Access, PowerPoint, Outlook) and internet applications.
- Strong organizational, analytical, interpersonal, writing, and verbal communication skills.
- Ability to manage priorities, deadlines, and work well under pressure.
- Adaptability, independence in completing tasks, and ability to collaborate effectively as part of a team.
- Commitment to a team problem-solving approach using a research and patient-focused model.
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.
- Demonstrated 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 REDCap and electronic data capture systems.
- Experience working with Electronic Medical Records (Epic preferred).
- 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.
Benefits
NYU Langone Health provides a comprehensive benefits and wellness package, including:
- Financial security benefits (retirement savings, insurance, etc.).
- A generous time-off program.
- Employee resource groups for peer support.
- Access to a holistic employee wellness program focusing on physical, mental, nutritional, sleep, social, financial, and preventive care well-being.
Pay
The salary range for this role is $70,481.61 - $88,236.75 annually. Actual salaries depend on factors such as experience, specialty, education, and hospital need.