Research Coordinator

Hospital for Special Surgery•New York, NY

3d•$56,000 - $85,250

About The Position

The Clinical Research Coordinator will be an integral member of the research team in compliance with all regulatory, institutional, and departmental requirements. The candidate will play an integral role in day-to-day research activities and patient coordination; ensuring efficient operations. 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 clinical studies. 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. Someone who is interested in clinical research long term is preferred.

Requirements

1-3 years of experience in clinical research preferred
Bachelor’s degree minimum
Knowledge of Good Clinical Practice and Good Technology Practice
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

Nice To Haves

Prior hospital experience
Prior Epic experience
Knowledge of Orthopaedic and/or Rheumatologic terminology is a plus
A flexible schedule that allows for variable shifts throughout the week is a plus

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 the supervision of multidisciplinary teams involved in the successful conduct of the study as well as research assistants I and II assigned to independent research studies.
Spearheads efforts to meet patient enrollment targets related to independent research studies. To that end, develops and implements various recruitment strategies.
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 (radiology, operating room staff, pathology, pharmacy, etc.).
Ensures accuracy of personnel transcribing data from a paper case report form (CRF) into an electronic format.
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.
Directs research assistants in this effort as well.
Coordinates with Principal Investigator, ancillary department, central research administration, and compliance office to help 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 Institutional Review Board, Principal Investigator, National Institutes of Health and/or sponsor for each research project.
Participates in the development of new protocols, prospective databases and new initiatives taken on by the department.
This may include independent design of databases and tools to facilitate data collection as required for specific projects (calendars, schedules, tracking logs).
Represents the Principal Investigator in departmental audits as well as external audits performed by representatives of the sponsor for each clinical research project.
Works closely with HSS internal monitor for guidance on these activities.
Collaborates 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.
Prioritizes and schedules work activities to ensure that workflow is controlled and meets the need of the department.
Communicates and maintains institutional/departmental policies, standard operating procedures, quality standards, improvement initiatives and external legal regulations/regulatory requirements.
Knowledge of good clinical practice for the handling of specimens and blood may be required.
Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of research data management.
A qualified candidate has the ability to communicate in an effective manner with management, clinical staff, external sponsors and patients at HSS.
We are also looking for someone who is interested in clinical research long term.