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, assist in obtaining informed consent, collect, maintain and organize study information, and assist 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.

Essential Functions and Responsibilities Includes the Following:

1. Coordinates activities of ongoing clinical trials
   • Assists in the 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); educate 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.

1. Manage study data of ongoing clinical trials under supervision of the PI(s):
   • Ensure accurate and complete compilation of subject data through chart reviews.
   • Collect and record study data on Case Report Forms (CRFs) and submit forms in a timely manner according to study guidelines.
   • Meet with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol.
   • Maintain source documents and subject files in accordance with White Plains Hospital’s (WPH) Standard Operating Procedures (SOPs).
   • Assist with analyzing data as needed.

1. 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.
   • Assist the PI and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
   • Participate in Investigators’ Meeting and assist with coordinating Study Initiation Visits.
   • Attend divisional/departmental/institutional educational and training seminars.
   • Contact local physicians to obtain source documentation and subject survival status.
   • Educate new staff regarding overview of clinical research, office policy and procedures, data submission, patient registration and specimen handling.

1. Understands and adheres to the WPH Performance Standards, Policies and Behaviors.
2. Performs all other related duties as assigned.

Education & Experience Requirements

Experience:

• 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

Education:

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

Core Competencies

• Coordinates clinical trial activities accordance to the protocol such as screening, subject registration, schedule of

• study visits, etc.
• Prepares, processes, handles, and ships biospecimen samples to the appropriate lab as outlined by the
• sponsors, lab manual, or protocol.
• Maintains and enters data for ongoing clinical trials
• Assists regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials

Clinical Trial Management

• Track and manage assigned protocols and subject enrollments
• Coordinate study visits with internal staff, vendors, and the sponsor.
• Create and maintain tracking for all safety reporting, all required deviations/violations, etc.

Stakeholder Engagement

• Establish and maintain regular communication with study team including the PI’s, study sponsor, and applicable

• regulatory agencies to ensure all required information is communicated.
• Serve as liaison for study team, clinical team and sponsor with regard to study status information, safety issues,
• upcoming protocol amendments and consent changes and applicable protocol training.

Leadership and Professionalism

• Maintain working knowledge of current regulations, regulatory guidance and or local policies.
• Assists Clinical Research Director with regulatory based training and implementation of new or revised regulation,

• guidance and or local policy.
• Present study and subject status updates at applicable research meetings.
• Protocol oversight; monitoring and reporting of study events; data collection; adherence to study protocols; inservice
• education of physicians, nurses, and support staff to protocol requirements; coordinate research activities.

Physical/Mental Demands/Requirements & Work Environment

• May be exposed to chemicals necessary to perform required tasks. Any hazardous chemicals the employee may be exposed to are listed in the hospital’s SDS (Safety Data Sheet) data base and may be accessed through the hospital’s Intranet site (Employee Tools/SDS Access). A copy of the SDS data base can also be found at the hospital switchboard, saved on a disc.

Primary Population Served

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The responsibilities and tasks outlined in this job description are not exhaustive and may change as determined by the needs of White Plains Hospital.