Regulatory Project Manager Job at University of North Carolina at Chapel Hill
University of North Carolina at Chapel Hill Chapel Hill, NC 27599
$53,772 - $67,000 a year
Posting Information
Department
Globl Hlth and Infect Disease-427801
Career Area
Research Professionals
Is this an internal only recruitment?
No
Posting Open Date
05/16/2023
Application Deadline
05/26/2023
Position Type
Permanent Staff (SHRA)
Position Title
Soc/Clin Research Specialist - Journey
Salary Grade Equivalent
GN11
Working Title
Regulatory Coordinator
Position Number
20037380
Vacancy ID
P017467
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
Work Location
Chapel Hill, NC
Position Location
North Carolina, US
Hiring Range
$53,772 - $67,000
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 primary purpose of this position will be to prepare submissions to IRB and other regulatory bodies including external IRBs, FDA and NIH and communicate with staff, sponsors, and monitors regarding regulatory issues for clinical trial protocols, including multicenter and IND studies. This person will work within the regulatory department of the Institute for Global Health and Infectious Diseases ongoing clinical research studies. Main responsibilities include:
- Perform independent and dependable work in preparation and coordination of study submissions to IRB (UNC ethics board) and other appropriate committees following regular deadlines
- Communicate with study staff, IRB, sponsors, domestic and international study partners in a courteous and professional manner
- Meet with study sponsor representatives as needed
- Prepare informed consent forms that follow appropriate regulations and meet sponsor requirements
- Address queries and memos from IRB and other regulatory authorities, prepare clinicaltrial.gov submission
- Maintain and organize electronic and paper regulatory documents and study files
- Perform Quality Assurance/Quality Control of study files
- Track and enter regulatory submissions using an electronic database, prepare reports using the database
- Participate in guideline development as appropriate, streamline processes
- Aid in training of study staff on regulatory procedures and compliance issues, adverse events, and protocol deviations
- Communicate potential issues to regulatory supervisor, study team members, investigators
- Assist other staff members in completion of work in a team-oriented fashion
- Complete other regulatory duties as assigned
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
This person must be detail-oriented and conscientious and be comfortable communicating with a diverse audience.
Preferred Qualifications, Competencies, and Experience
- Advanced degree in science.
- Experience working in clinical research.
Required Licenses/Certifications
Special Physical/Mental Requirements
Campus Security Authority Responsibilities
Not Applicable.
Position/Schedule Requirements
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