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Position Summary:
We have an exciting opportunity to join our team as a Senior Clinical Research Coordinator. 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, and is responsible for the day-to-day execution and coordination of a diverse clinical research portfolio focused exclusively on EGIDs. The portfolio includes industry-sponsored, government-funded, investigator-initiated, foundation-supported, and unfunded studies across multiple designs, including retrospective, prospective, survey-based, interventional, and 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. Many studies will not have CRO infrastructure or dedicated management support, so 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.
The ideal candidate will be capable of identifying priorities, resolving operational barriers, and advancing studies efficiently in a fast-paced academic environment. This role is best suited for a research professional with broad experience across academic and sponsor environments, strong regulatory knowledge, excellent attention to detail, and the ambition to grow long-term within clinical research.
This role offers the opportunity to help shape and grow a multidisciplinary EGID research program within academic medicine.
Job 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 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 startup 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:
To qualify you must have a Bachelor's Degree or equivalent combination of education and experience required. Professional certification (ACRP CCRC or SOCRA CCRP) required. Computer literate with good interpersonal, writing and verbal communication skills. Must have 4 years relevant clinical experience required with a minimum of one year as a CRC in the CCU. Effective oral, written, communication, interpersonal skills. Must be able to work under the direction of supervision Ability to identify, analyze and solve problems. Time management skills and ability to work well under pressure. Proficiency in using various Microsoft Office applications such as Word, Excel, Access, PowerPoint and Outlook. Familiar with Internet applications Intermediate competency in medical terminology, and Good Clinical Practice (GCP) guidelines, Federal Regulation that govern the conduct of human subjects research as well as Institutional Review Board and institutional policies and procedures related to human subjects research. Proficient analytical, interpersonal, writing and verbal communication skills. The ability to manage priorities and deadlines and maintain service level expectations for tasks. Adaptability, independently completes tasks and works within deadlines and collaborate effectively as part of a team. Commitment to team problem-solving approach using a research and patient-focused model. Ability to identify, analyze and solve problems. Ability to multi-task and prioritize in a fast-paced work environment, time management skills and an ability to work well under pressure. Organizational skills both to function independently and as a member of a professional team. Ability to work with diverse groups of people. Effective oral, written, communication, interpersonal skills. Must be able to work under the direction of supervision.
Preferred Qualifications:
Bachelors degree required. Masters 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.
Required experience includes 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.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family.
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. We require applications to be completed online.
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NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $70,481.61 - $88,236.75 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
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