RN Manager Clinical Research

UNC Health; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

UNC Health is seeking an experienced clinical research administrator to oversee the quality, coordination, and conduct of all aspects of clinical research administration at the UNC Medical Center Cancer Center Research Raleigh unit.

The role ensures safety, ethics and integrity in research, guides staffing, budgeting, and collaboration with physicians and study sponsors to maximize viable trials and timely enrollment.

Qualifications

• Ability to read, analyze, and interpret clinical information.
• Ability to write reports and procedure manuals.
• Ability to communicate with patients, physicians, family members and managers.
• Ability to manage budgets and track regulatory elements.

Responsibilities

• Staffing to meet research dept needs; hiring, orientation, training and evaluation.
• Direct clinical research operations per ICH GCP; develop policies and ensure IRB adherence.
• Prepare and maintain budget accountability; report financial status to Director.
• Promote collaboration to maximize viable clinical trials and improve care.
• Assess feasibility; process trials through committees until enrollment opening.
• Track trials with key indicators and report to management.
• Ensure clinical staff involvement to identify trials and PI approvals.
• Collaborate with sponsors/monitors to meet timelines and milestones.
• Negotiate study budgets to align with requirements and milestones.

Skills

Clinical research knowledge

Regulatory compliance

Communication skills

Budget management

Education

Bachelor's degree in nursing

Master's degree preferred

Job description

Description

Your passion belongs at UNC Health. Join more than 56,000 teammates working together to improve the health and well-being of the communities we serve across North Carolina.

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 Information

Education Requirements

• Bachelor's degree in nursing required. Master's degree preferred.

Licensure/Certification Requirements

• RN NC LIC
• Preferred: CCRP

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 Details

• Legal 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.
• Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, status as a protected veteran or political affiliation.
• UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities. All interested applicants are invited to apply for career opportunities. Please email [e-mail] if you need a reasonable accommodation to search and/or to apply for a career opportunity.