Regulatory Assistant

UNC-Chapel Hill; Chapel Hill (NC); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Benefits package including health,Life

Discounts on campus events

Child care savings

Professional training opportunities

Job summary

UNC-Chapel Hill’s Lineberger Comprehensive Cancer Center seeks a Social/Clinical Research Assistant to support regulatory document collection and management for oncology clinical trials. The role ensures compliance with federal regulations, GCP, and institutional policies, handling essential documents, IRB submissions, and regulatory binder maintenance.

The position emphasizes collaboration with study teams, maintaining documentation accuracy, and aiding in training and process improvements to

Qualifications

• Bachelor’s degree or equivalent combination of training and experience.
• Proficiency with Microsoft Office and ability to organize and present information.
• Knowledge of regulatory policy for oncology clinical research and IRB procedures.

Responsibilities

• Prepare and maintain essential regulatory documents and binders.
• Coordinate IRB applications and continuing reviews.
• Track regulatory actions and provide updates at meetings.
• Assist in training Regulatory team members.
• Ensure compliance with federal regulations and GCP.

Skills

Communication skills

Regulatory compliance knowledge

IT literacy

Education

Bachelor’s degree (or equivalent)

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Full-time/Part-time Permanent/Time-Limited

Full-time/Part-time Permanent/Time-Limited Full-Time Permanent

If time-limited, estimated duration of appointment

This position is not eligible for H-1B sponsorship.

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.

University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC -Chapel Hill offers full-time employees a comprehensive benefits package , paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

Primary Purpose of Organizational Unit

The UNC Lineberger Comprehensive Cancer Center ( LCCC ), founded in 1975, is a designated National Cancer Institute (NCl)-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 LCCC’s Clinical Trials Office ( CTO ) is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The CTO 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 CTO 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.

Position Summary

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

Regulatory Essential Document Collection and Regulatory Binder Maintenance

• Preparing, collecting, and obtaining signatures for essential documents for electronic regulatory binder, including delegation of authority/delegation of task log, financial disclosure forms, Form FDA 1572, training documentation, protocol signature page, IB acknowledgments, lab certifications, medical licenses, CVs
• Maintaining regulatory binder, including naming regulatory documents in accordance with defined nomenclature, filing regulatory documents in eRegulatory binder in accordance with defined filing structure
• Communicating with sponsors and monitors regarding status of essential regulatory documents and providing essential documents as required
• Tracking and recording pending regulatory actions through completion on study team trackers
• Providing updates on status of pending regulatory actions at study team meetings (oral and/or written) and takes meeting minutes
• Accurately entering IRB approval information into the electronic clinical research management system (OnCore) and uploading study documents into OnCore within required deadlines
• Other duties as assigned

Monitoring and Auditing Compliance

• Preparing regulatory binder for monitoring and audit visits and addresses regulatory findings within required deadlines.

Portfolio Management: Regulatory IRB Applications

• Preparing, submitting, and processing in a timely and accurate manner IRB applications for:
• continuing reviews for closed to accrual studies with all patients off treatment to the IRB of record
• personnel modifications to UNC IRB
• external IND safety reports to UNC IRB

Process Improvements

• Developing, writing and providing input on standard operating procedures, work instructions, and internal processes.
• Mentoring new Regulatory team members
• Participating on CTO committees/task forces/working groups
• Assisting in training Regulatory team members as needed
• Attending pre-study team regulatory meetings for assigned study teams

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.

Minimum Education and Experience Requirements

Bachelor’s degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Management Preferences

Working knowledge and facility with information technology, including Microsoft Outlook, Word, Excel, and PowerPoint; ability to organize, record, and present information; ability to lead exchange of information through dialog, instruction, and demonstration; ability to develop working knowledge of regulatory requirements and procedures relating to essential document collection for oncology clinical research; ability to communicate professionally both verbally and in writing. Knowledge of regulatory policy relating to clinical research and institutional review boards.

Required Licenses/Certifications

Special Physical/Mental Requirements

Position requires sitting for extended periods of time.

Campus Security Authority Responsibilities

Not Applicable.

Position/Schedule Requirements

Evening work occasionally, Overtime occasionally, Weekend work occasionally

Office of Human Resources Contact Information

If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at [phone] or send an email to [e-mail]

Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.

Equal Opportunity Employer Statement

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.

Required Documents

• Curriculum Vitae / Resume
• Cover Letter

Optional Documents

• List of References

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

• * Please select the response below that best describes your experience/education for the Social/Clinical Research Assistant position.
  • Bachelor's, Master's, and/or Doctorate in any field.
  • Associate's in any field and at least 2 years of experience.
  • Combination of post-high school education and experience to equal at least 4 years of related experience (ex: 1 year towards a degree and 3 years of experience).
  • High School diploma/GED and at least 4 years of related experience.
  • Did not complete high school but have a combination of high school education and experience to equal 8 years. (ex. 3 years of high school and 5 years of experience).
  • None of the above
• * Have you received training in GCP and ICH Guidelines?
  • Yes
  • No
• * Do you have prior social clinical research experience?
  • YES
  • NO
• * Briefly describe your experience and proficiency with Microsoft Office (Word, Excel, Outlook).

  (Open Ended Question)