"Clinical Research Nurse 3"

Overview

As a regarded member of the Gynecologic Oncology Division Clinical Trials Office, the Clinical Research Nurse supports the conduct of clinical research protocols in the Department of Obstetrics, Gynecology & Reproductive Sciences.

Required Skills and Abilities

1. Provides primary oversight of day-to-day clinical and operational processes for moderately to highly complex protocols.
2. Collaborates with key external business partners, division, and institutional leadership to ensure business needs are met.
3. Manages, implements, and evaluates all aspects of clinical trial conduct including study initiation, maintenance, and completion.
4. Approves study feasibility, coverage analysis and budget reviews based on analysis of the protocol and knowledge of clinical trial operations, ICH /GCP, federal regulation and institutional processes.
5. Advises Principal Investigator through updates on portfolio, protocol issues, safety reviews, and compliance matters.
6. Analyzes research portfolio for competing studies, alignment with local standard of care practices, and anticipating future market trends.

Principal Responsibilities

1. Manages, implements, and evaluates clinical research trials, studies and projects.
2. Designs activities, policies and procedures to improve day to day efficiency of the recruitment and assessment components of the study and to ensure that staff members perform activities within established research protocol.
3. Develops and implements procedures and data quality assurance standards for safety monitoring components of studies.
4. Writes and edits study protocol.
5. Develops administrative policies to ensure that staff are performing activities within established protocol, guidelines and federal regulations.
6. Provides immediate and urgent medical care to subjects experiencing medical complications
7. Reports critical events and adverse reactions.
8. Prepares and adjusts recruitment and assessment study plans by designing strategies and analyzing data related to these components.
9. Trains, develops goals and supervises a team of research staff in the details of the study protocols. Monitors staff schedules, productivity and performance.
10. Leads committees or task forces to address and resolve significant operational issues.
11. May perform other duties as assigned.

Required Education and Experience

Bachelor’s of Science Degree in Nursing and six years of related experience or an equivalent combination of education and experience.

Required License(s) or Certification(s)

Licensure as Registered Nurse in the State of Connecticut or Connecticut license eligible.

Salary Range

$92,000.00 - $146,750.00

Location

310 Cedar Street, New Haven, Connecticut

Work Model

Hybrid

Time Type

Full time