Senior Clinical Research Coordinator

UNC-Chapel Hill • Chapel Hill, NC

5d

About The Position

This position will serve as a Senior Clinical Research Coordinator within the Department of OB- GYN , Center for Women’s Health Research. The Senior Clinical Research Coordinator is responsible for the planning, organization, conduct, and evaluation of multi-faceted clinical research protocols, including study execution, developing strategies and solutions to improve study processes and execution, providing reviews of other team members’ work product, and serving as mentor and subject matter expert. This position manages team members that work closely with study subjects and other research staff and supervises most steps of the research study process to collect, compile, document, and analyze clinical research data; reviews research documentation, reports, and graphs while overseeing appropriate logs, the tracking of participants, and the preparation of study materials; collaborates with key departments and leaders to accomplish strategic goals and objectives, fostering interdisciplinary teamwork and enhancing the hospital/medical group’s reputation as a leader in a specific area of research; manages the daily operations of the Clinical Research program, ensuring adherence to standards for good clinical practice ( GCP ) and compliance with guidelines and regulations from the office of Human Research Protection ( OHRP ), the Food and Drug Administration ( FDA ), and local or central institutional review boards ( IRB ), maintaining the highest standards of ethical conduct in research; supports the growth and development of the research program, identifying opportunities for expansion, collaboration, and research excellence, and advocating for resources and support; supervises multiple clinical trials simultaneously, ensuring research activities are completed efficiently, optimal use of resources and timely execution of research protocols; reviews data collection of patient charts, medical records, interviews, and diagnostic tests, as well as reviews comprehensive documentation, ensuring the accurate and reliable analysis of research data; works with the CWHR post-award staff to oversee REI studies’ budgets, ensuring financial accountability and efficient resource allocation to support the successful execution of research projects; supports the growth and development of the Clinical Research program, identifying opportunities for expansion, collaboration, and research excellence, and advocating for resources and support to further advance oncology research within the hospital/medical group industry; conducts nursing duties as required per protocol; oversees study coordinators and research assistants working on REI research studies.

Requirements

• Strong written and verbal communication skills.
• Must be able to work and communicate with diverse populations effectively and professionally.
• Ability to work independently as well as function as part of a team.
• Proficient with Microsoft Outlook, Excel, and Word.
• 5-7 years’ experience, including direct experience as a Clinical Research Coordinator
• Certification (or anticipated certification within 6 months) in clinical research or human subject research
• Registered Nurse (RN) licensure

Nice To Haves

• N/A

Responsibilities

• Planning, organization, conduct, and evaluation of multi-faceted clinical research protocols
• Study execution
• Developing strategies and solutions to improve study processes and execution
• Providing reviews of other team members’ work product
• Serving as mentor and subject matter expert
• Managing team members that work closely with study subjects and other research staff
• Supervising most steps of the research study process to collect, compile, document, and analyze clinical research data
• Reviewing research documentation, reports, and graphs while overseeing appropriate logs, the tracking of participants, and the preparation of study materials
• Collaborating with key departments and leaders to accomplish strategic goals and objectives
• Fostering interdisciplinary teamwork and enhancing the hospital/medical group’s reputation as a leader in a specific area of research
• Managing the daily operations of the Clinical Research program, ensuring adherence to standards for good clinical practice ( GCP ) and compliance with guidelines and regulations from the office of Human Research Protection ( OHRP ), the Food and Drug Administration ( FDA ), and local or central institutional review boards ( IRB ), maintaining the highest standards of ethical conduct in research
• Supporting the growth and development of the research program, identifying opportunities for expansion, collaboration, and research excellence, and advocating for resources and support
• Supervising multiple clinical trials simultaneously, ensuring research activities are completed efficiently, optimal use of resources and timely execution of research protocols
• Reviewing data collection of patient charts, medical records, interviews, and diagnostic tests, as well as reviews comprehensive documentation, ensuring the accurate and reliable analysis of research data
• Working with the CWHR post-award staff to oversee REI studies’ budgets, ensuring financial accountability and efficient resource allocation to support the successful execution of research projects
• Supporting the growth and development of the Clinical Research program, identifying opportunities for expansion, collaboration, and research excellence, and advocating for resources and support to further advance oncology research within the hospital/medical group industry
• Conducting nursing duties as required per protocol
• Overseeing study coordinators and research assistants working on REI research studies

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed