Clinical Research Coordinator

Hospital for Special Surgery • New York, NY

10d • $56,000 - $85,250

About The Position

How you move is why we’re here. ® Now more than ever. Get back to what you need and love to do. The possibilities are endless... Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize the abundant opportunities for growth and success. If this describes you then let’s talk! HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment. Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise.

Requirements

• Bachelor’s degree required, Masters preferred
• 2+ years of experience in clinical research required; ACRP or SOCRA Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) preferred
• Prior experience with REDCap / EHRs (e.g., EPIC) / Electronic Data Captures, IRB Management platforms
• Knowledge of Human Subjects research regulations and HIPAA compliance; FDA regulations for clinical trials; Good Clinical Practice;
• Knowledge of Orthopaedic and/or Rheumatologic terminology is preferred

Responsibilities

• Coordinates clinical research activities for the ARJR service under the direction of the Industry Director, Clinical Research and serves as a liaison between the PIs/Sub-Is, Sponsors, CROs, Service Research Leadership, and other research staff to ensure protocol adherence and study efficiency.
• Supports all phases of study conduct including feasibility, start-up, activation, enrollment, follow-up, monitoring, and close-out activities.
• Contributes to all aspects of ARJR industry research including: Assisting with protocol development and informed consent forms Recruitment and Enrollment process (conducts pre-screening, eligibility assessments, and informed consent process under PI supervision) Schedules and coordinates research study visits, facilitates completion of study procedures and assessments; Maintains real-time subject calendars and study tracking logs throughout study lifecycle to ensure visit adherence and completion of protocol requirements o Monitors and tracks reportable events including adverse events (AEs/SAEs), protocol deviations, device issues, and unanticipated problems under PI supervision; Promptly notifies PI of potential AEs/SAEs for review and reconciliation and ensures timely Sponsor/IRB reporting and documentation maintenance · Ensures that all research related regulatory, institutional, and departmental compliance requirements are met as appropriate.
• Responsibilities associated with specific studies include but are not limited to: Facilitates completion and submission of all documentation needed for research (e.g., IRB applications, amendments, reportable events, continuing reviews to ensure study renewals, conflict of interest forms, data collection forms, etc.) Facilitates completion and submission of Enrollment Milestones and invoiceable items via CTMS SMART for billing reconciliation; ClinicalTrials.gov registration, updates, and results reporting, in compliance with federal and institutional requirements o Maintains complete and audit-ready regulatory binders, including delegation of authority logs, training records, all IRB, Sponsor, and FDA correspondenceo Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of clinical research project management.o May handle and ship biospecimens

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees