Regulatory Associate
- Employer
- University of North Carolina at Chapel Hill
- Location
- Chapel Hill, NC
View more
- Institution Type
- Four-Year Institution
Job Details
To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.
Salary Grade EquivalentGN11Full-time/Part-time Permanent/Time-LimitedFull-Time PermanentIf time-limited, estimated duration of appointmentHours per week40Work ScheduleMonday – Friday; 8:00 a.m. – 5:00 p.m.
Department Name and NumberLCCC - Clinical Trials-426806Date First Posted10/12/2020Closing Date10/16/2020Position LocationChapel Hill, NCPosition Posting CategoryResearch ProfessionalsDepartment DescriptionThe UNC Lineberger Comprehensive Cancer Center, founded in 1975, is a National Cancer Institute (NCI)-designated comprehensive cancer center. The Center’s mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach.
Equal Opportunity EmployerThe 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 DescriptionUNC Lineberger Comprehensive Cancer Center’s Clinical Protocol Office is recruiting for 2 Social/Clinical Research Specialist (Regulatory Associate) positions. By applying to this posting you will be considered for both positions: 20037249 and 20001001.
This position is responsible for regulatory compliance of an assigned disease group(s) which includes providing regulatory guidance and training to investigators and CPO staff; preparing and submitting required regulatory documents and responses to regulatory bodies (e.g., Institutional Review Boards (IRB)); and creating and maintaining professional working relationships with investigators, sponsors, team members, and others. These responsibilities relate to the UNC/LCCC CPO mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.
Minimum Education and Experience RequirementsBachelor’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 AbilitiesDemonstrated ability to provide consultation and lead exchange of research information through technical assistance and instruction. Demonstrated ability to train others, including documenting steps needed to collect information and to independently provide consultation to sites or others related to the specific protocols and regulatory guidance. Demonstrated ability to write comprehensive reports summarizing results and conveying to supervisory personnel. Demonstrated ability to plan work to meet objectives and deadlines.
Preferred QualificationsSignificant use of information technology is expected for this position. Experience in clinical research preferred, including familiarity with CFR Parts 50, 54, 56, 312, 314 and ICH Guidelines. CCRP, CCRC, CIRB or RAC Certification preferred. A cover letter is encouraged as an example of professional written communication skills. Master’s degree or higher preferred. CCRP, CCRC, CIRB or RAC Certification preferred.
Required Licenses/Certifications Special Physical and Mental RequirementsRequires sitting for extended periods of time. Ability to move 25 pounds. Ability and willingness to push cart with files between 4-5 buildings.
Position/Schedule RequirementsPosition AttributesStimulus/ARRA FundedNoQuick Linkhttp://unc.peopleadmin.com/postings/184401Office of Human Resources Contact InformationIf you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to employment@unc.edu
Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.
Applicant DocumentsRequired Documents- Curriculum Vitae / Resume
- Cover Letter
Required fields are indicated with an asterisk (*).
- * Please select the response below that best describes your experience/education for the Social/Clinical Research Specialist position.
- Bachelor's in a discipline related to the field assigned and at least 1 year of related training or experience.
- Associate's, Bachelor's, Master's, Doctorate in an unrelated field and at least 5 years of related training and/or experience.
- Master's and/or Doctorate in a discipline related to the field assigned.
- Associate's in a discipline related to the field assigned and at least 3 years of related training or experience.
- Combination of post-high school education and experience to equal at least 5 years of experience related to the field assigned (ex: 1 year towards a degree and 4 years experience).
- Did not complete high school but have a combination of high school education and related experience to equal at least 9 years (ex. 3 years of high school and 6 years of experience).
- None of the above
- * Have you received training in GCP and ICH Guidelines?
- yes
- no
- * Do you have experience submitting regulatory documents to regulatory bodies (e.g., Institutional Review Boards)?
- yes
- no
- * What are your interests in the field of clinical research?
(Open Ended Question)
- * Do you have experience drafting informed consent forms?
- yes
- no
- * Please describe your experience with multiple, concurrent projects.
(Open Ended Question)
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
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert