Regulatory Associate

Job description

Position Type:

Permanent Staff (SHRA)

Is this an internal only recruitment?:

No

Position Title:

Soc/Clin Research Specialist - Journey

Working Title:

Regulatory Associate

Position Number:

20038061, 20038062

Vacancy ID:

P012522

Budgeted Hiring Range:

$53,772 - $60,000

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 a.m. – 5:00 p.m.

Department Name and Number:

LCCC - Clinical Trials-426806

Date First Posted:

03/26/2021

Closing Date:

06/08/2021

Position Location:

Chapel Hill, NC

Position Posting Category:

Research Professionals

Department Description:

The 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.

UNC Lineberger’s Clinical Protocol Office (CPO) is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The Protocol Office provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval and implementation processes of protocols conducted at UNC and its affiliate institutions. The Protocol Office is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large.

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.

UNC Lineberger’s Clinical Protocol Office (CPO) is recruiting for two Regulatory Associates. By applying to this recruitment you will be considered for both positions: 20038061 and 20038062.

The Regulatory Associate 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 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:

Demonstrated 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 Qualifications:

Significant 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.

Special Physical and Mental Requirements:

Ability to lift/move 25 pounds and ability to move cart with files between 4-5 buildings with or without accommodation.

Position/Schedule Requirements:

Evening work occasionally, Weekend work occasionally

Stimulus/ARRA Funded:

No

 

 

 

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Job No:
Posted: 6/6/2021
Application Due: 6/12/2021
Work Type: Full Time
Salary: