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MANAGER, CLINICAL RESEARCH (RN)

Saint Francis Health System
New Haven, CT, United States
Full-time

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Full Time

Job Summary : The Manager, Clinical Research (RN) manages the day-to-day operations for the clinical research service line including program development in partnership with the Saint Francis Health System leadership team, researching engagements and giving operational oversight for locations within the research department.

This role facilitates the general pre- award start-up activities, project management and post-award activities for active projects and works closely with key internal and external stakeholders to ensure the efficient and compliant initiation, ongoing administrative management and support of trial research which further develop and support the goals and mission of the health system.

Minimum Education : Has completed the basic professional curricula of a school of nursing as approved and verified by a state board of nursing, and holds or is entitled to hold a diploma or degree therefrom.

Bachelor of Science in Nursing, required.

Licensure, Registration and / or Certification : Valid multi-state or State of Oklahoma Registered Nurse License.

Work Experience : Minimum five years of experience in clinical trial management in a hospital, clinic, or physician office setting required, preferably in an integrated health system.

Minimum three years of experience managing and supervising a research team or five years leadership experience in the clinical research capacity.

Minimum two years of experience in contract and budget development, preferred.

Knowledge, Skills, and Abilities : Knowledge of Microsoft 365. Sound knowledge of clinical study processes and federal and state research compliance regulations.

Effective oral and written communication skills with the ability to communicate complex information effectively to internal and external stakeholders.

Ability to design and implement systems for education, monitoring, recordkeeping, and process design and the use of evidence for decision making.

Ability to manage, motivate, and mentor team members and others involved in clinical trial processes. Excellent organizational and data management including the ability to manage project budgets and timelines.

Essential Functions and Responsibilities : Manages all research activities within the department including adherence to good clinical practice guidelines, applicable regulations and project management throughout the lifecycle of a clinical trial involving the feasibility, start-up, engagement, follow-up and closeout stages of the trial.

Assists leadership with clinical research contracts and budget guaranteeing ethical, legal, and financial parameters are upheld.

Oversees and allocates department resources within budgeted targets to include recruitment, orientation and performance management of departmental staff.

Ensures adherence to all regulatory requirements mandated by each study including federal regulations and guidelines. Monitors data entry and tracking in the Clinical Trials Management System (CTMS) to ensure completion of tasks in a timely matter that meets established set timeframes, monitors other productivity measures including study activity, researching financials and volume data by service line or specialty.

Establishes and promotes a culture of individual accountability for quality assurance and improvement and adherence to the health system's mission, vision, and values.

Evaluates performance standards and measurements to support compliance with protocol, good clinical practice, FDA and other research regulatory requirements.

Maintains positive relationships and interfaces with physicians to identify high priority clinical studies, coordinates study selection committee and serves as liaison to study sponsors to attract new studies.

Performs the duties of departmental Research Coordinator and / or Nurse Navigator (Research), as needed.

Decision Making : The carrying out of non-routine procedures under constantly changing conditions, in conformance with general instructions from a supervisor.

Working Relationships : Direct Supervision of others. Prepares and gives performance evaluations. Works directly with patients and / or customers.

Works with internal and / or external customers via telephone or face to face interaction. Works with other healthcare professionals and staff.

Works frequently with individuals at Director level or above.

Special Job Dimensions : None.

Supplemental Information : This document generally describes the essential functions of the job and the physical demands required to perform the job.

This compilation of essential functions and physical demands is not all inclusive nor does it prohibit the assignment of additional duties.

Clinical Research and Sponsored Programs - Yale Campus

Location :

Tulsa, Oklahoma 74136

EOE Protected Veterans / Disability

5 days ago
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