Summary: Oversees the quality, coordination and conduct of all aspects of clinical research administration to ensure that research is conducted safely, ethically, and with the highest integrity.
Responsibilities:- Responsible for efficient staffing to meet research department needs. Responsible for the hiring process, orientation of new coworkers, training and evaluation of the coworkers performance to ensure safe, quality patient care, protection for research subjects, and to ensure Rex standards of performance are met.
- Provides direction for the clinical research operation in accordance with ICH GCP guidelines and based on established regulatory, professional, organizational standards. Develops, implements, maintains policies and procedures. Ensures IRB policies and procedures are followed.
- Prepares and maintains accountability for research departmental budget and utilization of resources. Identifies variances and measures taken to address the variance. Regularly reports to Director financial status of the department.
- Promotes collaboration among physicians, members of the healthcare team, and other departments with the objective of maximizing the number of viable clinical trials in order to improve quality, optimize care, and improve participant and physician satisfaction.
- Works collaboratively with medical staff and appropriate department representatives to determine feasibility of studies and processes the trials through the required committees/meetings until trial is opened and approved for enrollment.
- Develops and maintains mechanism to track each clinical trial opened to include key indicators in order to provide regular reports to management. Develops mechanism to track clinical, regulatory, and fiscal elements of each trial.
- Assures active Medical Staff involvement to identify clinical trial opportunities and obtain involvement as principal investigators (PI). Works with appropriate representatives to obtain concurrence on appropriateness of clinical trials under consideration.
- Responsible for ensuring collaboration with study sponsors and monitors to facilitate the ongoing need to collect data and meet study related, contracted timelines for study milestones.
- Responsible for sound financial management by negotiating study budgets in line with study requirements and meeting contractual milestones for enrollment, data timelines, etc.
Other InformationEducation Requirements:- Bachelor's degree in nursing required. Master's degree preferred.
Licensure/Certification Requirements: Professional Experience Requirements:- Five years of clinical research experience. Three years of management experience. Clinical research certification preferred. Prefer hospital based research experience.
Knowledge/Skills/and Abilities Requirements:- Language Skills: Ability to read, analyze, and interpret clinical information, professional journals and technical procedures. Ability to document clinical information. Ability to write reports and procedure manuals. Ability to effectively communicate information and respond to questions from patients, physicians, family members and groups of managers.
- Mathematical Skills: Ability to calculate figures and amounts such as discounts, interest, commissions proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
- Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Job DetailsLegal Employer: STATE
Entity: UNC Medical Center
Organization Unit: Cancer Center Research Raleigh
Work Type: Full Time
Standard Hours Per Week: 40.00
Pay offers are determined by experience and internal equity
Work Assignment Type: Onsite
Work Schedule: Day Job
Location of Job: US:NC:Raleigh
Exempt From Overtime: Exempt: Yes
This is a State position employed by UNC Health Care System with UNC Health benefits. If, however, you are presently an employee of another North Carolina agency and currently participate in TSERS or the ORP, you will be eligible to continue participating in those plans at UNC Health.
