Clinical Research Coordinator, HSS Center for Regenerative Medicine

Hospital for Special Surgery•New York, NY

3d•Onsite

About The Position

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. The CRC will be in compliance with all regulatory, institutional, and departmental requirements; maintains regulatory binders, liaises with communications and preparation of documents for the FDA; participates in all aspects of research management and quality assurance of data for the Principal Investigator. The successful applicant for the position of Clinical Research Coordinator will be a highly motivated and organized individual who is able to perform a variety of different tasks essential to the implementation and successful completion of a clinical study. He or she should be knowledgeable of regulations regarding Human Subjects research and assure HIPAA compliance. The applicant must be able to multitask and prioritize research projects. A qualified candidate will have the ability to communicate in an effective manner with management, clinical staff, external sponsors and patients at HSS. The candidate will also have good interpersonal and writing skills, as he or she will interface directly with patients and medical staff on a routine basis. He or she will be flexible, as the job description may evolve as studies progress. The applicant must be available on site at the main hospital.

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).
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

Nice To Haves

Knowledge of Orthopedic and/or Rheumatologic terminology is preferred.

Responsibilities

Oversees and conducts the informed consent process on studies as appropriate (requires appropriate training and certification of human research subjects training).
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.
This includes collaboration with multidisciplinary teams involved in the successful initiation and conduct of clinical research studies and clinical trials (clinical research administration, legal, finance, compliance, etc.).
Spearheads efforts to meet patient enrollment targets related to independent research studies. To that end, develops and implements various recruitment strategies and provides regular enrollment updates to the Principal Investigator.
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. This requires coordination with both the research subject, either by phone, email, or mail per compliance and with physician office staff and ancillary departments.
Manages and executes IRB submissions for initial approvals, re-approvals, amendments, etc. Ensures timeliness and accuracy of submissions and no lapses in approvals for the study.
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.
Provides timely reports to the Institutional Review Board, Principal Investigator, Research Director, National Institutes of Health and/or sponsor for each research project.
Participates in the development of new protocols, prospective databases and new initiatives. This may include independent design of databases and tools to facilitate data collection as required for specific projects (calendars, schedules, tracking logs).
Collaborate with the research team and research administration, as needed, to ensure that research subjects are treated in accordance with all mandated requirements.
Ensures that standards regarding subject registration, protocol specific tests, and required documentation are adhered to.
Reports deviations as appropriate and resolves issues when possible. Escalates issues to supervisor as needed.
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.