Job Description

Employment Type: Permanent Staff (EHRA NF)

Vacancy ID: NF0008526

Salary Range: Dependent on Qualifications/Experience

Position Summary/Description:

The purpose of Regulatory Associate is to facilitate the conduct of oncology clinical trials by ensuring regulatory compliance with federal regulations, Good Clinical Practice, and local and institutional policies. In particular, this position is responsible for:

* Preparing, submitting, and processing regulatory applications, forms and documents required to conduct clinical research at UNC LCCC to the to the Institutional Review Board ( IRB ) and ancillary committees, including the Protocol Review Committee ( PRC ), Data Safety Monitoring Committee ( DSMC ), Institutional Biosafety Committee ( IBC ), Compliance Committee, and Radiation Safety Subcommittee ( RSS )
* Preparing informed consent forms, HIPAA documents, and participant materials 
* Ensuring regulatory compliance for assigned disease groups, including timely and accurate reporting of unanticipated problems and noncompliance events to the IRB , contributing to development of CAPAs and root causes analyses for non-compliance events, and tracking and recording pending regulatory and compliance actions through completion on study team trackers and in clinical trial management system 
* Providing updates (oral and/or written) on status of pending regulatory actions and compliance at study team and compliance meetings 
* Preparing for monitoring and audit visits and addressing regulatory findings within required deadlines
* Assisting with the maintenance of the regulatory binder, including entering regulatory and study information in the electronic clinical trial management system (OnCore) and eRegulatory binder (Florence). 

The Regulatory Associate also includes involvement in process improvements and training such as writing and reviewing standard operating procedures and work instructions, mentoring new Regulatory team members, participating on Clinical Trials Office ( CTO ) committees, and assisting in training Regulatory team members.

These responsibilities relate to the UNC / LCCC clinical research mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.

Education and Experience:

Experience preparing and maintaining IRB applications, including initial, continuing review, amendment modification, and expedited report submissions, for:
* therapeutic clinical research studies involving a drug or device, and/or
* oncology clinical research studies 
Experience using an eRegulatory system (such as Florence) 
RAC , SoCRa, or ACRP certification preferred.

Essential Skills:

Demonstrated experience in clinical research, including advanced knowledge of 21 CFR Parts 50, 54, 56, 312, 314, 812 and ICH GCP Guidelines. 
Possess strong decision-making skills and the ability to problem solve and troubleshoot issues
High level of accuracy and attention to detail
Experience preparing and submitting accurate and complete IRB submissions and consent forms.
Demonstrated ability to provide consultation and lead discussions regarding regulatory actions and compliance. 
Solid writing skills and ability to prepare comprehensive reports
Demonstrated ability to plan work to meet objectives and deadlines. 
Demonstrated ability to communicate effectively and professionally verbally and in writing
Strong computer skills, including working knowledge and facility with Outlook, Word, Excel, and PowerPoint. 
Ability to work on evenings, weekends and/or holidays occasionally required.
A cover letter is required as an example of professional written communication skills.

AA/EEO Statement:

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, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.

About The University of North Carolina at Chapel Hill

Carolina rates among the nation’s great institutions of higher education, set on an historic and beautiful campus that celebrates all four seasons. Carolina’s students, faculty and staff come here from around the world, bringing varied cultural, racial and ethnic heritages that help make UNC-Chapel Hill a thriving intellectual center. We’re repeatedly ranked the nation’s best value in higher education for students seeking to earn a college degree – the University has garnered the top spot each time since the ranking’s launch in 1998.Whether you’ve just started your career, are new to academia or are a seasoned professional with assorted campus experiences to draw on, we hope you will find a great place at Carolina.

Connections working at The University of North Carolina at Chapel Hill

Job Tags

Holiday work, Permanent employment, Local area, Weekend work, Afternoon shift,

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