Clinical Research Coordinator

Sr. Clinical Research Coordinator

The Sr. Clinical Research Coordinator (CRC) plays a pivotal role in managing the Eosinophilic Gastrointestinal Diseases Program. This position requires overseeing a wide array of clinical research studies, including industry-sponsored, government-funded, and investigator-initiated projects. The ideal candidate will navigate these studies with minimal support, ensuring compliance and organizational standards are upheld from startup to closeout. This role demands a professional with significant experience in academic and sponsor environments, possessing strong regulatory knowledge and attention to detail.

Responsibilities

• Independently manage a portfolio of 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 Principal Investigator 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 Principal Investigator 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 Principal Investigator 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 research program.

Essential Skills

• Proficient in chart review, clinical research, regulatory processes, and IRB submissions.
• Strong skills in chart extraction and data management.
• Ability to independently manage and prioritize multiple studies and tasks.

Additional Skills & Qualifications

• Bachelor's degree required.
• Experience in pediatrics is a plus.

Work Environment

This role is part of a clinical research team in a hybrid environment, involving both onsite and remote work. The position requires direct interaction with patients on investigator-initiated and funded trials. The work setting is fast-paced and demands a high degree of autonomy and initiative.

Job Type & Location

This is a Contract position based out of New York, NY.

Pay and Benefits

The pay range for this position is $39.00 - $43.00/hr eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the…