Job Location (Full Address):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400054 Medicine M&D-Cardiology Div

Work Shift:

UR - Day (United States of America)

Range:

UR URCA 214 H

Compensation Range:

$35.35 - $47.72

Responsibilities:

This position supports the Cardiology Division as a research nurse coordinator for the clinical operations of the unit. This position requires a nursing degree with strong clinical skills, with a preferred background in cardiology nursing. Typical duties will include but are not limited to evaluating study protocols regarding standard of care and research-oriented tasks, evaluating time effort needed to complete clinical tasks and study procedures and visits related to conduct of the studies. The duties will also include conducting study protocols as the primary coordinator being responsible for enrollment and entire conduct of given study under the direction of Principal Investigator. On-call responsibilities are expected and dependent on individual study protocols. This position will assist the administrative efforts of the Manager of the Unit regarding regulations of WIRB, RSRB, patient Accounting, and the funding sponsors in study start-up and management of pharmaceutical device clinical trials, drug studies, and investigator-initiated trials. This person will be committed to providing high quality research efforts on the Cardiology Division's behalf.

Reports to the Manager of the Cardiology Clinical Trials Unit

ESSENTIAL FUNCTIONS

• Coordinates the administrative details required to initiate and conduct human subject research, such as, receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials to immediate team members and relevant others.
• Ensures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures and standards for documentation and communication. Under general direction from the Principal Investigator, trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and case report form (CRFs) completion, and adverse event reporting.
• Recruiting/screening/consenting/enrollment of patients, record reviews and interviews, history and physicals across multiple units.
• Dispensing of investigational medications and devices, performing procedures as required by protocols (obtaining lab specimens, performing electrocardiograms, collecting data while observing electrophysiology, diagnostic, interventional cardiology procedures, exercise testing, drawing of bloods, etc.).
• Develop good working relationship with sponsors and multiple research institutions to foster a positive research environment and attend study Investigator/Coordinator meetings as required for study start-up.  Assist in training new staff members within the department.
• Filling out case report forms, creating patient instructions and calendars, scheduling patient appointments, and assisting the investigators as needed.
• Reviews and documents the dispensing and returning of study materials (such as study drugs and devices). Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
• Report serious adverse events to sponsor and Cardiology Administration
• Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE

• Associate's degree in Nursing required
• Bachelor's degree in Nursing preferred
• 1 year clinical trials experience preferred
• Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

• Phlebotomy skills for adult and pediatric patients and good computer skills required
• Independent and organized professional with superior interpersonal skills, sound judgment and good oral and written communication skill required
• Strong clinical skills preferred
• Cardiology background and research experience preferred
• Knowledge of word processing and data analysis software preferred

LICENSES AND CERTIFICATIONS

• RN - Registered Nurse - State Licensure and/or Compact State Licensure in NYS upon hire required
• Professional Research Coordinator Certification (i.e. SoCRA or ACRP) preferred