Job Description

RN - Nursing at Yale New Haven Health summary:

This role involves coordinating and managing clinical research protocols within a hospital setting, ensuring compliance with FDA regulations and Good Clinical Practice guidelines. The RN supervises patient care related to research studies, recruits eligible patients, collects data, and oversees administrative and financial aspects of clinical trials. Required qualifications include an RN license, clinical research experience, certification preference, and strong communication and organizational skills.

Overview

To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.

At Bridgeport Hospital, we are committed to providing quality medical care and treatment that is coordinated and centered on the patient's specific needs. We strive to achieve benchmarks as a Patient Centered Medical Home and provide health care in a setting where patients are at the center of their care team. All employees of Bridgeport Hospital are part of the patients care team and contribute to the team approach of promoting access, continuous, comprehensive care and work to provide quality improvement in the care provided to their patients.

Organizes, manages, coordinates and supervises all assigned research protocols entered into by the Department of Medicine. Complies with GCP's (Good Clinical Practice) guidelines and follows all FDA regulations with regard to clinical trials.Essential duties and responsibilities include the following. Other duties may be assigned.

EEO/AA/Disability/Veteran


Responsibilities

• 1. Coordinates initiation of new research protocols.
• 1.1 Collects study protocol data (Informed consent and required IRC outline) as required by each study for presentation to IRC as indicated by review of IRC minutes.
• 2. Recruits and enrolls eligible patients into assigned study.
• 2.1 Screens and recruits appropriate patients, following inclusion/exclusion criteria set forth by protocol.
• 3. Oversees patient care as related to study protocol.
• 3.1 Initiates procedures (labs, ECGs, Vital sign, physical exam) as defined by study protocol within appropriate time limits.
• 4. Maintains appropriate data collection as mandated by study protocol.
• 4.1 Gathers tests results (BW,ECGs, V.S.) as mandated by protocol with guidelines set by study.
• 5. Oversees administration and financial issues related to protocol.
• 5.1 Responsible for processing of contract in conjunction with Bridgeport Hospital legal counsel, Sponsor, and Principal Investigator.
• 6. Demonstrates patient and personnel safety.
• 6.1 Maintains policies and procedures for Infection Control as outlined in the Bridgeport Hospital policy manual.
• 7. Performs accurate documentation of screening and/or enrollment necessary to meet legal standards and FDA requirements.
• 7.1 Writes legibly when making entries in the medical record and includes signature and professional status.
• 8. Maintains educational guidelines and maintains skills knowledge base to assure competency.
• 8.1 Maintains educational record as indicated by random review of records.

Qualifications

EDUCATION

*

EXPERIENCE

3-5 years experience in clinical specialty, Experience with clinical pharmaceutical/device trials

LICENSURE

CRC (Clinical Research Coordinator) Certification preferred (ACRP)

SPECIAL SKILLS

Current RN CT license, Basic word processing skills and database maintenance, Strong communication and interpersonal skills, Demonstrated organization and time management skills, BLS certified

PHYSICAL DEMAND

o While performing the duties of this job, the employee is required to use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is required to stand,sit and walk. The employee may occasionally move and/or lift up to 25 pounds. The specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. The noise level in the work environment is usually moderate.

Additional Information

Clinical research experience strongly preferred.


YNHHS Requisition ID

153965

Keywords:

registered nurse, clinical research coordinator, clinical trials, patient care, FDA compliance, Good Clinical Practice, data collection, research protocols, hospital nursing, patient recruitment

Job Tags

Contract work,

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