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Clinical Trials Quality Assurance Program Coordinator

Employer
University of North Carolina at Chapel Hill
Location
Chapel Hill, NC
Closing date
Jul 23, 2021

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Job Details

Position Type:

Permanent Staff (SHRA)

Is this an internal only recruitment?:

No

Position Title:

Soc/Clin Research Specialist - Journey

Working Title:

Clinical Trials Quality Assurance Program Coordinator

Position Number:

20012642

Vacancy ID:

P013021

Budgeted Hiring Range:

$53,700 - $68,000

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 Permanent

Hours per week:

40

Work Schedule:

Monday – Friday, 8:00 AM – 4:30 PM

Department Name and Number:

Clinical Trials-621200

Date First Posted:

07/08/2021

Closing Date:

07/20/2021

Position Location:

Chapel Hill, NC

Position Posting Category:

Research Professionals

Department Description:

The core mission of the Office of Clinical Trials (OCT) is to ensure compliance with federal, state, and institutional requirements, supporting the Human Research Protection Program by conducting post IRB approval reviews of clinical studies, research billing reviews, monitoring ClinicalTrials.gov and conducting compliance checks prior to project account set up. This includes education, consultation, and guidance on the conduct of clinical trials. The OCT serves as a central resource for UNC faculty, staff and departments involved in clinical trials research and for sponsors seeking to conduct clinical trials at UNC by:

  • Serving as the point of contact for questions or issues related to clinical trials
  • Provide assistance and consultation in budget development and preparation
  • Developing and providing education and training on the requirements and procedures related to the conduct of clinical research
  • Assisting researchers, staff, and departments with clinical trial project development
  • Serving as an expert resource for information on the issues and requirements for the conduct of clinical research
  • Developing and implementing programs and initiatives, based on monitoring and assessment, to enhance the quality of clinical research and to support regulatory compliance
  • Providing oversight and assisting with registration of clinical trial information and posting of results as appropriate in clinicaltrials.gov

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:

The Clinical Trials Quality Assurance (CTQA) Program Coordinator will review/audit human subjects research for compliance with the terms and conditions of the IRB approval, sponsor or grant agreement, governing laws and regulations, Good Clinical Practice (GCP), and UNC-CH policies/procedures. The selected candidate will meet and discuss the reviews with the Principal Investigator (PI) and study team. A written report of the review will be provided to the PI/study team at the completion of the audit.

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.

Essential Skills, Knowledge and Abilities:

The selected candidate must demonstrate the following:

  • Expert knowledge of US federal, state, and local regulations related to clinical research studies, including, but not limited to: 45CFR46, 21CFR312 and 812, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, GCP, University policies, and Office of Human Research Ethics standard operating procedures (SOPs)
  • Ability to interpret and understand research protocols for adherence to compliance
  • Proficiency with medical terminology and electronic health records
  • Excellent communication skills
  • Strong organizational skills and attention to detail
  • Strong time management and prioritization skills
  • Ability to critically analyze problems and provide solutions
  • Ability to conduct audits both on and off campus, including, but not limited to, hospital areas, clinics, community settings
  • Strong computer skills, including proficiency with Microsoft Office
  • Ability to work effectively both independently and as part of a team

Preferred Qualifications:

  • 5 years of experience in clinical research involving human subjects
  • Previous experience monitoring or auditing clinical research involving human subjects
  • SOCRA CCRP or ACRP CCRC/CCRA certification
  • Working knowledge of databases
  • Strong customer service skills

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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