REGULATORY COORD

Job description

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.


Operations:
For complex scenarios, recognizes when all types of agreements are necessary. Directs teams to appropriate Duke offices for execution. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Maintains study level documentation for international studies. May develop resources and tools for management of international studies, and/or coordinate with other entities or offices. Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits. Develops or helps develop SOP.. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).


Ethics:
Under supervision may collect information about AEs, identified in the protocol or investigator brochure. Develops consent plans and documents for participants in a variety of studies. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.

Data:
Independently uses and implements technology to enhance productivity or process. May train or oversee others.

Science:
Using scientific proposals from the PI, develops research protocols. Demonstrates a basic understanding of the elements of research study designs.

Study and Site Management:
Prepares for and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. Ensures that studies are conducted in compliance with institutional requirements and other policies. Prepares studies for closeout and document storage.



Leadership:
Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Actively facilitates and leads multiple study team's adoption of change in their working environment. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.


Description of Portfolio Responsibilities: (Effort .%):


Type of Research:
This position will support the IRB submission and maintenance process for the Division of Infectious Disease. The position will assist investigators and clinical research staff in writing consent forms and other documents consistent with Duke IRB requirements. The position will assist with sponsor visits and maintain study level documentation for the assigned study portfolio. The position will be supervised by the ID team Lead CRC, Sr. and will work in conjunction with the ID Team Regulatory Coordinator, Sr. who will manage the higher complexity regulatory.

Special skills:
Prefer experience with iRIS, good writing skills, as well as ability to utilize computer software easily.

Minimum Qualifications

Education

Completion of an Associate's degree

Experience

Work requires a minimum of two years of research and/or regulatory experience. experience. A Bachelor's degree may substitute for 2 years of required

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

 

 

 

Diversity Profile: University

 

AAUP COMPENSATION SURVEY DATA

View more

Learn more on Inside Higher Ed's College Page for University

Arrow pointing right
Job No:
Posted: 1/9/2021
Application Due: 4/9/2021
Work Type: Full Time
Salary: