Clinical Research Coordinator, HSS Center for Regenerative Medicine

Hospital for Special Surgery•New York, NY

8d•$57,500 - $87,500•Onsite

About The Position

Integrated in the HSS Center for Regenerative Medicine, the Clinical Research Coordinator works closely with Sports Medicine physicians serving as Principal Investigators and reports directly to the AVP, Clinical Operations Officer and Chief Pharmacy Officer. The coordinator manages all aspects of clinical research studies, including patient screening and enrollment, biospecimen collection, data management, protocol development support, IRB submissions, and coordination of clinical and laboratory activities. The role requires compliance with study protocols, ICH Good Clinical Practice, human-subjects regulations, HIPAA, and applicable FDA, institutional, and departmental requirements. The coordinator maintains regulatory binders, supports FDA-related communications and document preparation, and participates in research management and data quality assurance. The position involves regular interaction with patients, physicians, clinical staff, management, external sponsors, and multidisciplinary research and administrative teams. The successful candidate is organized, motivated, able to multitask and prioritize projects, and must be available onsite at the main hospital. Job duties may evolve as studies progress.

Requirements

Bachelor’s degree.
3–5 years of experience in clinical research.
Deep knowledge of FDA regulations for clinical trials.
Knowledge of human-subjects research regulations and HIPAA compliance.
Knowledge of Good Clinical Practice for handling specimens and blood.
Proficiency with computers and software, including Microsoft Excel, Outlook, PowerPoint, and Word.
Excellent verbal and written communication, organizational, problem-solving, customer-service, and interpersonal skills.
Strong attention to detail and ability to multitask and prioritize research projects.
Familiarity with electronic data capture platforms such as REDCap and EMR platforms such as Epic.
Availability to work onsite at the main hospital.

Nice To Haves

Master’s degree.
ACRP, SOCRA, or similar certification.
Knowledge of orthopedic and/or rheumatologic terminology.

Responsibilities

Screen and enroll patients according to study inclusion and exclusion criteria.
Oversee and conduct informed consent processes when appropriate, with required human-subjects training and certification.
Collect biospecimens in office and operating-room settings, and assist with their collection, transport, processing, and storage for laboratory use.
Manage study data collection, including measurements, patient-provided clinical data, protocol duties, and advanced data queries.
Coordinate clinical and laboratory activities and collaborate with multidisciplinary clinical, research, legal, finance, compliance, and administrative teams.
Develop and implement patient recruitment strategies to meet enrollment targets and provide regular enrollment updates to Principal Investigators.
Schedule research visits and follow-ups within protocol timeframes and ensure required assessments and procedures are completed.
Manage initial, continuing, and amended IRB submissions, ensuring accuracy, timeliness, and uninterrupted study approvals.
Coordinate with Principal Investigators, ancillary departments, research administration, and compliance offices to ensure studies follow applicable regulations and sponsor policies.
Prepare timely reports for the IRB, Principal Investigator, Research Director, National Institutes of Health, and/or study sponsors.
Participate in developing protocols, prospective databases, and new initiatives; design databases and data-collection tools as needed.
Ensure subject registration, protocol-specific testing, and required documentation meet standards; report deviations, resolve issues when possible, and escalate issues as needed.
Maintain regulatory binders and assist with FDA communications and document preparation.
Support research management and quality assurance of data for the Principal Investigator.
Maintain professional growth through seminars, professional affiliations, and internal training.