Regulatory Coordinator
- Employer
- University of North Carolina at Chapel Hill
- Location
- Chapel Hill, NC
View more
- Administrative Jobs
- Academic Affairs, International Programs
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
Job Details
Permanent Staff (SHRA)
Is this an internal only recruitment?:No
Position Title:Soc/Clin Research Specialist - Journey
Working Title:Regulatory Coordinator
Position Number:20037803
Vacancy ID:P012352
Budgeted Hiring Range:$53,508 - $59,747
Pay Band Information:To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.
Salary Grade Equivalent:GN11
Full-time/Part-time Permanent/Time-Limited:Full-Time Time-Limited
If time-limited, estimated duration of appointment:3 years
Hours per week:40
Work Schedule:Monday – Friday; 8am-5pm
(Hours may vary based on project needs)
Globl Hlth and Infect Disease-427801
Date First Posted:02/05/2021
Closing Date:03/04/2021
Position Location:Chapel Hill, NC
Position Posting Category:Research Professionals
Department Description:The Division of Infectious Diseases conducts investigator-initiated, industry-funded, NIH funded AIDS prevention and treatment, sexually transmitted infections, other infectious diseases scientific and clinical research, and provides patient care at UNC-Chapel Hill and at sites throughout the world. The University of North Carolina is dedicated to developing and conducting research on HIV prevention, HIV infection as well as conducting research in other infectious diseases.
Equal Opportunity Employer:The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
Position Description:THIS IS A REPOST. PREVIOUS APPLICANTS ARE STILL BEING CONSIDERED AND NEED NOT REAPPLY.
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 on
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 a 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.
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.
Essential Skills, Knowledge and Abilities:This person must be detail-oriented and conscientious and be comfortable communicating with a diverse audience.
Preferred Qualifications:- Advanced degree in science
- Experience working in clinical research
Evening work occasionally, Overtime occasionally, Weekend work occasionally
Stimulus/ARRA Funded:No
Organization
The nation’s first public university is at the heart of what’s next, preparing a diverse student body to become creators, explorers, innovators and leaders in North Carolina and throughout the world. Carolina’s nationally recognized, innovative teaching, campus-wide spirit of inquiry and dedication to public service continue the legacy that began in 1795 when the University first opened its doors to students.
Here, in one of America's most beautiful college settings, we offer exceptional careers in richly diverse fields. Come explore what UNC-Chapel Hill has to offer you.
Undergraduate Enrollment: 19,117
Graduate/Professional Enrollment: 10,894
Total Student Enrollment: 30,011
Founded: 1789, as the first state university in the United States
Type of Institution: Public, four-year
Undergraduate Admission: 15,961
Graduate/Professional Enrollment: 10,039
Total Student Enrollment: 26,000
Faculty: 3,000
Percentage of faculty who hold Ph.D.s or the highest degrees in their field: 94 percent
Faculty/student ratio: 1/14
Location: UNC is located in the heart of Chapel Hill, the best college town in America! It's a friendly town of about 40,000 in the geographical center of North Carolina. Chapel Hill is at the western point of the Research Triangle, an area of about one million people, comprised of Chapel Hill, the cities of Durham and Raleigh, and the Research Triangle Park, home of many corporate offices and scientific research centers. Carolina is about 30 miles from the state capital, Raleigh, and 20 minutes from Raleigh-Durham International Airport.
Chapel Hill's main street, Franklin Street, borders the campus and offers shops, coffee houses, cafés, movie theaters and houses of worship. The town has a historic district, museum, library, parks, malls, and many recreational facilities.
Origins of Carolina's students: 82 percent of UNC's freshmen are from North Carolina and 18 percent are from out-of-state. Our students come from 42 different states and our international students represent 37 countries.
Size of freshman class: Approximately 3,400
Class size: Barely five percent of undergraduate classes contain more than 100 students; two-thirds of undergraduate classes have fewer than 30 students. Forty-one percent have fewer than 20 students, including First Year Seminars, in which first-year students work closely with professors.
Sports and athletic programs: UNC is an NCAA Division I school with 28 varsity teams. Carolina is the proud home of the Dean Smith Center, Kenan Stadium, Carmichael Auditorium, Koury Natatorium, and many other fine athletic facilities. Students join more than 60 intramural and club sports, which include baseball, bowling, crew, golf, lacrosse, rock climbing, rugby, tae kwon do, and ultimate frisbee. The Student Recreation Center offers weight training, aerobics, stair machines, and all the equipment you would expect to find at a great health club! Carolina offers a newly renovated outdoor pool and indoor pools, a golf course, tennis courts, and the longest zipline in America!
Number of residence halls: Incoming undergraduates will live in one of Carolina's 29 residence halls, which are wired for Internet access and cable television. housing.unc.edu
Scholarships and financial aid: About 40 percent of UNC-Chapel Hill students receive scholarships and/or some form of financial aid. studentaid.unc.edu
Special research institutes: Institute for Research in Social Science, Institute of Outdoor Drama, Morehead Planetarium, Kenan Institute of Private Enterprise, Institute of Government, Institute of African American Research.
Career services: On-campus counseling, job fairs, résumé writing service, internships, placement services. www.unc.edu/depts/career
Technological facilities: Students find multiple uses for Carolina's state-of-the-art technological resources. They can access Carolina's computer services through Academic Technology and Networks, which manages academic computing, e-mail, microcomputing labs, interactive media presentation, video and classroom support, and a help desk. The MetaLab oversees the development of SunSITE, one of the world's busiest digital library and electronic publishing projects.
Students may open e-mail accounts, and many use campus computer resources to construct personal Web pages. Students in residence halls have hardwired network connections to the Internet and cable television in their rooms. At the ATN Training center, students may take classes on software packages and utilities. Computer labs are available for student use all over campus.
Carolina Computing Initiative: Beginning with the freshman class of 2000, undergraduates must purchase laptop computers. The University has arranged for IBM to offer computers at excellent prices. Students, faculty, and staff will enjoy cost savings, higher quality compatible equipment, and better technical support through CCI. www.unc.edu/cci
The Study Abroad program allows students to live and learn in Europe, the Middle East, Asia and the Pacific Rim, Africa, and the Americas. www.unc.edu/depts/abroad
The Honors Program offers special seminars, research programs, and the chance to design your own independent studies. www.unc.edu/depts/honors
Carolina students spend time in public service through student organizations, the Campus Y, the Carolina Center for Public Service, and courses that incorporate community service.
UNC's chapter of Phi Beta Kappa, a national collegiate honor society, is the oldest in North Carolina, dating from 1904. There are many other honorary societies at Carolina.
UNC offers ROTC programs in all branches of national military service.
Through the First Year Seminars program, first year students will understand what it means to study at a premier research university. They will learn from faculty members and share in their research in seminars of no more than 20 students.
Life outside the classroom: More than 370 clubs, teams, and student organizations offer something for everyone! You can choose from among musical and dramatic performing groups, publications, ethnic and religious clubs, the Campus Y and other service organizations, fraternities and sororities, and pre- professional organizations. Whatever your interests, you will find others at Carolina who share them! www.unc.edu/depts/union/student/listintr.htm
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