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About the Role

Integrated in the Center for Regenerative Medicine (CRM), the Clinical Research Coordinator will work closely with Sports Medicine physicians (Principal Investigators) and will directly report to the AVP, Clinical Operations Officer and Chief Pharmacy Officer. Responsible for all aspects of clinical research studies including but not limited to, screening and enrolling patients following inclusion/exclusion criteria, collecting biospecimens both in the office setting and the OR, data management activities while assuring compliance with protocols and ICH GCPs, assisting with protocol development, submitting new and continuing review to the IRB, and coordinating clinical and lab activities to integrate all protocol activities.

Responsibilities

Oversees and conducts the informed consent process on studies as appropriate.
Manages data collection specific to research studies including but not limited to the performance of measurements for applicable studies, collection of clinical data from patients directly, and manages the performance of all other duties as put forth in the protocol.
Spearheads efforts to meet patient enrollment targets related to independent research studies.
Ensures subject research visits and follow-ups are scheduled within the protocol specified time frame and that all required assessments and procedures are performed per the protocol.
Manages and executes IRB submissions for initial approvals, re-approvals, amendments, etc.
Coordinates with Principal Investigator, ancillary department, central research administration, and compliance office to ensure that clinical research and related activities are performed in accordance with federal and HSS regulations and sponsoring agency policies and procedures.
Performs advanced data queries when needed.
Participates in the development of new protocols, prospective databases and new initiatives.
Collaborate with the research team and research administration, as needed, to ensure that research subjects are treated in accordance with all mandated requirements.
Assists in collecting, transporting, processing, and storing biospecimens obtained from research patients to the lab.
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 and regenerative medicine.

Requirements

Bachelor’s degree; Master’s preferred
ACRP, SOCRA, or similar certification preferred
3-5 years’ experience in clinical research
Deep knowledge of FDA regulations for clinical trials
Strong organizational and problem-solving skills, attention to detail, as well as excellent written and communication skills are essential
Proficient use of computers and software
Familiar with electronic data capture platforms such as RedCap and EMRs platforms (Epic).
Must be available on site at the main hospital.

Skills

Proficiency in Microsoft Excel, Outlook, PowerPoint, and Word
Excellent verbal and written communication skills
Excellent organizational, problem-solving, customer service, and interpersonal skills
Ability to multitask
Knowledge of Good Clinical Practice for the handling of specimens and blood
Knowledge of Human Subjects research regulations and HIPAA compliance
Knowledge of FDA regulations for clinical trials
Knowledge of Orthopedic and/or Rheumatologic terminology is preferred.

Location

New York City

Work Type

Regular Full time
Day shift

Experience Level

3-5 years

Education Level

Bachelor's degree
Master's degree preferred
ACRP, SOCRA, or similar certification preferred

Salary/Compensations

$0.00 - $0.00

Benefits

Eligible for additional benefits consistent with the role.

About the Company

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.

Equal Opportunity

Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment.
Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.