Research Coordinator

Position Summary

Reporting dually to the Sr. Administrative Director of Neurosciences and the Director of Research, the Clinical Research Coordinator duties will include activities such as data collection and management of patient clinical information, timely collection of protocol‑related samples (including shipment to outside entities as required), assisting in obtaining informed consent, collecting, maintaining and organizing study information, and assisting with other day‑to‑day operations as required.

Research projects may involve multi‑centered cooperative group studies, single‑site studies, intergroup studies, industry studies, and investigator‑initiated studies. The individual who holds this position acts in accordance with all local, state, federal and IRB policies and procedures.

• Coordinates activities of ongoing clinical trials
  • Assists in activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires, coordinating participants’ study visits and procedures.
  • Assists in obtaining informed consent under supervision of the study investigator(s); educates participants regarding study requirements.
  • Screen patients for eligibility and register subjects with sponsoring agency.
  • Coordinate research team to ensure compliance with planned treatment protocol including required laboratory and radiographic testing.
  • Secure, deliver, and ship blood and/or tissue samples, radiographs, and other clinical specimens as required by protocol.
  • Act as liaison between investigator(s) and sponsoring agency.
  • Coordinate activities pertinent to the safeguarding of patients’ rights in research.
• Manages study data of ongoing clinical trials under supervision of the PI(s)
  • Ensures accurate and complete compilation of subject data through chart reviews.
  • Collects and records study data on Case Report Forms (CRFs) and submits forms in a timely manner according to study guidelines.
  • Meets with internal and sponsor‑appointed monitors to ensure accuracy of subject data and compliance with research protocol.
  • Maintains source documents and subject files in accordance with White Plains Hospital’s (WPH) Standard Operating Procedures (SOPs).
  • Assists with analyzing data as needed.
• Performs other job‑related duties as required, may include but not limited to:
  • Reports adverse events and serious adverse events in accordance with WPH Institutional Review Board (IRB)/CIRB/BRANY SOPs, sponsor guidelines, and federal regulations.
  • Assists the PI and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
  • Participates in Investigators’ Meetings and assists with coordinating Study Initiation Visits.
  • Attends divisional/departmental/institutional educational and training seminars.
  • Contacts local physicians to obtain source documentation and subject survival status.
  • Educates new staff regarding overview of clinical research, office policy and procedures, data submission, patient registration and specimen handling.
  • Understands and adheres to the WPH Performance Standards, Policies and Behaviors.
  • Performs all other related duties as assigned.

• Minimum of one (1) year of experience in the field of data entry or clinical research required.
• Experience submitting IRB applications (new and amendments) preferred.
• Knowledge of clinical trial federal, state, and local regulations preferred.
• Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) including tracked changes functionality required.
• Excellent interpersonal and communication skills required.
• Understands and adheres to the WPH Performance Standards, Policies and Behaviors.

• Bachelor’s degree required, in a relevant field preferred.
• Research certification (e.g., RAPS, ACRP, SoCRA or equivalent) preferred.

• Coordinates clinical trial activities accordance to the protocol such as screening, subject registration, schedule of study visits, etc.
• Prepares, processes, handles, and…