Clinical Research Nurse - RN at Rochester Regional Health – ROCHESTER, New York

Coordinates, facilitates and monitors the implementation of all group research protocols being conducted in accordance with departmental policy, institutional policy, sponsor/protocol requirements, and FDA regulations. Provides, manages and coordinates care for patients participating in a clinical trial and their families, and ensures compliance with the written protocol.

RESPONSIBILITIES:

Demonstrates in-depth advanced knowledge of current professional nursing theory, practice and techniques:

• Interprets and evaluates written standards relevant to services within area of practice.

• Monitors, reviews and implements current nursing practices in light of changing concepts, methods, techniques, and written standards of care.

• Demonstrates advanced nursing physical assessment skills.

• Works collaboratively with physicians, physician’s assistants, case managers, community health care providers, nursing staff, and leadership staff.

• Implements plan of care in a sate, effective, and professional manner.

Assists with adult medical care management of patients on clinical trials:

• Utilizing the nursing process, records and documents health appraisal data (history and physical findings) necessary to maintain, coordinate, and/or expedite required ancillary services in the appropriate health problems related to the performance of research activities to which the patient has consented, which may include the psychosocial, cognitive, physical, environmental, and personal assets of the patient/family.

• Examines enrolled study patients as required by the research protocol, and documents cardiovascular, respiratory, GI tract function, pain status, sensorium, wound condition, urinary tract function, and any other body system appropriate to the patient’s condition and/or study protocol requirements.

• Evaluates x-rays, EKGs, and other diagnostic measures as necessary and appropriate.

• Educates and counsels patients/families about the study protocol, the potential risks and benefits of study participation, alternative therapies, and other necessary informed consent requirements. Also educates and counsels concerning the disease state, prognosis, needed actions, and any anticipated psychological or social implications of study participation, as appropriate.

• Evaluates patients in outpatient clinics as necessary to fulfill protocol requirements.

Coordinates, implements and monitors clinical trials:

• Reviews new protocols for feasibility of implementation at RGH prior to submission for approval and communicates their impression to the Research Manager, Principal Investigator and the Medical Director of Clinical Research.

• Maintains thorough familiarity with all aspects of active study protocols being conducted by assigned department may also be called upon to assist with on-going inpatient trials.

• Educates nursing, pharmacy and clerical staff about new protocols or amendment implementation and their roles in the implementation.

• Participates in screening and enrollment of potential study patients/subjects in accordance with the inclusion and exclusion criteria of active protocols.

• Collects and records data and submits to sponsors as required. Completes screening forms, case report forms, adverse event reports, drug disposition records, and other study documents in an accurate and timely manner.

• Reconciles data queries in a timely manner by communicating with sponsors.

• Properly prepares, stores, and ships serum, plasma, and other body fluid specimens according to study protocol and sponsor requirements, including completion of accompanying laboratory requisitions.

• Maintains all study documents in a neat, orderly, and easily retrievable system.

• Assures that appropriate inventories of supplies and study drugs are available for each active protocol. Coordinates the participation of pharmacists in drug preparation and maintenance of drug disposition records according to protocol requirements.

• Participates with investigator in occasional out-of-town meetings as required and is available for local and regional travel as requested.

Sponsor Relations:

• Understands and honors all obligations to the sponsor or other third party as detailed in the written study agreement for each relevant, active protocol.

• Schedules, coordinates and participates in sponsor site and monitoring visits.

• Assists in the preparation and submission of all sponsor, FDA and IRB required regulatory documents.

• Assists in the preparation and submission of miscellaneous information and documents requested by the sponsor or other third party (e.g. surveys of potential patient/subject populations, laboratory normal values, etc.).

• Communicates copies of screening logs, enrollment logs, and other documents as requested according to the schedule established by each sponsor or other third party.

• Attends coordinator meetings as needed in preparation for initiating new projects.

Investigational Review Board and FDA Relations:

• Participates in the preparation of materials to submit to the IRB for review and approval of a new study protocol. This may include reviewing protocols, informed consent documents, required letters, and other documents as specified by IRB requirements. Attends IRB meetings to help defend submitted protocols, as necessary.

• Prepares and submits annual reports and study completion reports to the IRB as needed.

• Submits adverse event reports and other IRB or sponsor required documents during the conduct of a study.

• Participates in any FDA monitoring visits.

• Participates in other audits.

Demonstrates advanced skills in verbal and written communication, and functions effectively as educational resource:

• Identifies and prioritizes learning and teaching needs of patients.

• Collaborates with staff and peers.

• Participates in clinical seminars to enhance knowledge and growth.

Participates in activities designed to increase the individual’s knowledge base and promote the growth and development of the individual, the institution and the profession:

• Attains minimum continuing education required by the certifying body.

• Reads professional journals.

• Participates in professional or nonprofessional groups and organizations.

• Provides consultation, education and service to the community as needed for patient centered care.

• Performs other duties as directed.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in Nursing or equivalent combination of education and experience.

• Minimum 2 years of relevant experience, preferably as an RN or Research Coordinator.

• Current New York State Registered Nursing license

PREFERRED QUALIFICATIONS:

• Pediatric experience required; Ability to interact well with pediatric patients and patients’ families.

• 2-4 years of experience preferred.

• Strong analytical, communication, customer service, and interpersonal skills.