Study Coordinator
Full Time
Chapel Hill, NC 27599
Posted
Job description
Posting Information
Department
Peds-Children's Research Inst-412019
Career Area
Research Professionals
Is this an internal only recruitment?
No
Posting Open Date
10/18/2022
Application Deadline
03/31/2023
Position Type
Permanent Staff (SHRA)
Position Title
Soc/Clin Research Specialist - Journey
Salary Grade Equivalent
GN11
Working Title
Study Coordinator
Position Number
20051267
Vacancy ID
P016296
Full-time/Part-time Permanent/Time-Limited
Full-Time Permanent
If time-limited, estimated duration of appointment
Hours per week
40
Work Schedule
Monday – Friday, 8:00am – 5:00pm; with occasional need for evening/weekend work – flexibility important.
Work Location
Chapel Hill, NC
Position Location
North Carolina, US
Hiring Range
$53,772 - $65,000
Pay Band Information
To learn more about the pay band for this branch and role, please see
the Career Banding rates spreadsheet.
Position Summary Information
Primary Purpose of Organizational Unit
The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service.
OUR VISION
Our vision is to be the nation’s leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.
OUR MISSION
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.
Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.
Education: We will prepare tomorrow’s health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.
Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.
OUR VISION
Our vision is to be the nation’s leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.
OUR MISSION
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.
Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.
Education: We will prepare tomorrow’s health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.
Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.
Position Summary
The UNC Department of Pediatrics, Children’s Research Institute (CRI) supports research focused on childhood diseases and disorders in the Department and across the University, providing infrastructure for facilitating interdisciplinary and collaborative research efforts, advancing the health of children in NC and beyond.
Research efforts focused on human subjects from pediatric populations are supported by the CRI Pediatric Clinical Research Unit (Peds CRU). CRI Peds CRU provides pediatric clinical researchers infrastructure, including program management, regulatory support, data management, sample processing, training/mentoring, community building, space to conduct visits, and study coordinators.
The CRI serves as a hub, reaching out across the Department of Pediatrics, School of Medicine, the University of North Carolina, and beyond to actively assemble cross-disciplinary researchers. Peds CRU studies include diagnostic tests, early phase therapeutics, cohort studies, and randomized trials, pairing new investigators with experienced ones in the collaboration of these studies. The Department’s organizational component consists of 14 divisions, various off campus sites and additional cost centers, all of which are invited to participate in our clinical trial initiatives.
This position will directly support the diverse clinical research activities of the UNC Children’s Research Institute through participation in multiple research projects. The primary purpose of this position is to coordinate and manage clinical trials, providing pediatric clinical researchers the infrastructure and resources to conduct clinical research. The Study Coordinator has direct responsibility for day-to-day activities of several pediatric clinical trials involving both drugs and medical devices. Responsibilities include patient recruitment, study procedures, administration of survey/questionnaires and data collection and maintenance. This Study Coordinator in this position will navigate responsibilities based on protocols currently underway and those in development. Other responsibilities include the initiation and maintenance of IRB and other regulatory procedures.
Research efforts focused on human subjects from pediatric populations are supported by the CRI Pediatric Clinical Research Unit (Peds CRU). CRI Peds CRU provides pediatric clinical researchers infrastructure, including program management, regulatory support, data management, sample processing, training/mentoring, community building, space to conduct visits, and study coordinators.
The CRI serves as a hub, reaching out across the Department of Pediatrics, School of Medicine, the University of North Carolina, and beyond to actively assemble cross-disciplinary researchers. Peds CRU studies include diagnostic tests, early phase therapeutics, cohort studies, and randomized trials, pairing new investigators with experienced ones in the collaboration of these studies. The Department’s organizational component consists of 14 divisions, various off campus sites and additional cost centers, all of which are invited to participate in our clinical trial initiatives.
This position will directly support the diverse clinical research activities of the UNC Children’s Research Institute through participation in multiple research projects. The primary purpose of this position is to coordinate and manage clinical trials, providing pediatric clinical researchers the infrastructure and resources to conduct clinical research. The Study Coordinator has direct responsibility for day-to-day activities of several pediatric clinical trials involving both drugs and medical devices. Responsibilities include patient recruitment, study procedures, administration of survey/questionnaires and data collection and maintenance. This Study Coordinator in this position will navigate responsibilities based on protocols currently underway and those in development. Other responsibilities include the initiation and maintenance of IRB and other regulatory procedures.
Minimum Education and Experience Requirements
Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Required Qualifications, Competencies, and Experience
The coordinator will demonstrate full knowledge of clinical research principles, methods of data collection and analysis.
The coordinator will demonstrate basic knowledge of statistics and related information technology.
The coordinator must understand all aspects of GCP (Good Clinical Practice) to conduct clinical studies under the regulatory guidelines of the FDA and institutional IRB.
The coordinator must understand protocols and be able teach them to faculty, fellows, and clinic personnel.
The coordinator must possess exceptional interpersonal and communication skills.
The coordinator must have a working knowledge of computers and related research equipment.
The coordinator will demonstrate basic knowledge of statistics and related information technology.
The coordinator must understand all aspects of GCP (Good Clinical Practice) to conduct clinical studies under the regulatory guidelines of the FDA and institutional IRB.
The coordinator must understand protocols and be able teach them to faculty, fellows, and clinic personnel.
The coordinator must possess exceptional interpersonal and communication skills.
The coordinator must have a working knowledge of computers and related research equipment.
Preferred Qualifications, Competencies, and Experience
Experience in pediatric or adult clinical research is strongly desired but not required. Additional preferences, but not requirements, include recent direct experience with:
Candidates who have worked with children, built rapport with families of diverse backgrounds, and are self-motivated are highly sought.
- Clinical trials (including experience with UNC IRB processes, FDA regulatory requirements, ICH GCP guidelines, and EPIC)
- Evaluating protocols and consents for potential changes, when warranted, for feasible implementation at our study location in the targeted population
- Coordinating NIH multi-center clinical trials, including study startup, recruitment, study management, data collection, and closeout
- Competitive enrollment studies
- Monitoring vital signs (heart rate, blood pressure)
- Developing and negotiating budgets with industry partners
Candidates who have worked with children, built rapport with families of diverse backgrounds, and are self-motivated are highly sought.
Required Licenses/Certifications
Special Physical/Mental Requirements
Campus Security Authority Responsibilities
Not Applicable.
Position/Schedule Requirements
Night work occasionally, Weekend work occasionally
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