Research Coordinator

Hospital for Special Surgery•New York, NY

2d•Onsite

About The Position

This position coordinates clinical research activities for the ARJR service under the direction of the Industry Director, Clinical Research. The Research Coordinator 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. This role supports all phases of study conduct including feasibility, start-up, activation, enrollment, follow-up, monitoring, and close-out activities. The Research Coordinator contributes to all aspects of ARJR industry research.

Requirements

Bachelor’s degree required
2+ years of experience in clinical research required
Knowledge of Human Subjects research regulations and HIPAA compliance
Knowledge of FDA regulations for clinical trials
Knowledge of Good Clinical Practice

Nice To Haves

Masters preferred
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 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.
Assists with protocol development and informed consent forms.
Manages the 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.
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.
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.
Manages ClinicalTrials.gov registration, updates, and results reporting, in compliance with federal and institutional requirements.
Maintains complete and audit-ready regulatory binders, including delegation of authority logs, training records, all IRB, Sponsor, and FDA correspondence.
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.
May handle and ship biospecimens.