Cone Health

Clinical Research Nurse Lead

ID
2021-7231
Location
Medical Arts and Cancer Center
Work Location
US-NC-Burlington
Division : Name
Alamance Regional Medical Center
Department : Name
ARMC-CLINIC RESEARCH
Category
NURSING
Position Sub-Category
RN - CLIN RESEARCH
Position Type
Full Time
Employment Type
Employee
Exempt/NonExempt
Exempt
FTE
1.00
Work Hours
40
Provider Schedule (specific schedule)
Monday-Friday, 8:30 AM - 5:00 PM
On call Required
No
Sub Category
RN - Clinical Research

Overview

Clinical Research Nurse Lead, is a professional level title in the Clinical Research Nurse Family. Clinical Research Nurse Lead, plans, organizes, leads, and performs comprehensive advanced level clinical trial duties for multiple or complex clinical trials, focusing on the overall productivity and success of the clinical trials. They perform some patient related care and assessments independently and within the scope of their licensure. They receive little supervision and are active participants in decisions regarding the clinical research process. They often manage support staff or other Clinical Research Nurses.

Talent Pool: Nursing

Responsibilities


Manages a team of Clinical Research Nurses, laboratory, and/or support staff, including hiring, scheduling, workload, compensation, rewards, development, and performance management.

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Coordinates multiple clinical trials simultaneously, and manages multiple Principal Investigator relationships, including establishing and managing multiple budgets, ensuring full compliance with local, state and federal policies and procedures. Serves as the liaison with the sponsor for assigned studies.

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Oversees financial accounting of multiple clinical research projects, including budget development, billing reconciliation, and quality review; oversees quarterly review of all Principal Investigator accounts, performing a strategic analysis of PI research portfolios. Develops administrative and financial recommendations for department management and PIs for research portfolio review. Compiles data and documents during internal and external audits, and is ultimately responsible for quality of submissions.

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Performs quality assessment of performance and contributes to efficiency and effectiveness of trial operations.

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Performs all duties of the Clinical Research Nurse II.

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Qualifications


EDUCATION:
Required: Bachelor of Science in Nursing or higher level degree in Nursing.

EXPERIENCE:
Required: Four years of clinical research experience is required (related graduate degree may substitute for two years of experience)

LICENSURE/CERTIFICATION/REGISTRY/LISTING:
REQUIRED

Required:

State of North Carolina nursing licensure is required.

Obtain Good Clinical Practice certification within 30 days of hire and maintain without lapse.

Obtain Human Subjects Research certification within 30 days of hire and maintain without lapse.

PREFERRED

1. Understanding of ICH/GCP guidelines for human research

2. Understanding of Code of Federal Regulations for Human Subjects

3. Computer Competency including proficiency in Microsoft Office and EDC systems

4. Understanding Phases I-IV drug development processes

5. Technical skills related to the completion of a study visit as required by the protocol.

6. Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) is preferred.

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