School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Lead, coordinate, and perform study specific regulatory and safety reporting processes for a group of investigators, or an entire unit, department or division, in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes independently. Lead team in problem solving regulatory issues of moderate to complex scope.

This position is in the School of Medicine, Radio logy CRU, and is primarily regulatory.The person in this role serves as the regulatory expert for the Department. They have a key role of communication with our researchers for any and all compliance issues, as well as expert in solutions for the teams.This role also navigates and communicates the Radiology Protocol Review for researchers outside of radiology, who have research imaging needs.

Work Performed

Operations:
Works with institutional leaders and offices to handle complex issues related to contracts and agreements. Helps the research program resolve complicated contractual problems. Serves as an IND submissions expert resource. Assists junior staff to address FDA review or issues.Provides oversight and guidance to those preparing documents, annual reports, and amendments required by the FDA. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Serves as an expert resource across all study teams within the research portfolio for navigating regulatory compliance with international studies. Participates in or leads the development of institutional policies and guidance documents about managing investigational products (IP).Serves as expert resource and trainer to implement and comply with systems for man aging and documenting IP. Participates in or leads development of monitoring and audit training sessions and/or policies and guidelines for research program. Serves as an expert resource to address and correct findings. Participates in study team meetings.

Ethics:
Serves as an expert in AE identification and documentation, including liaising with and being knowledgeable about other resources at Duke. Assists with the development of consent plans and documents for participants. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review. Preparesand submits documents needed for regulatory and safe ty reporting to sponsors and other agencies. May train or oversee others.

Data:
Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends and recommends strategies to improve processes or retrain staff. Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke. Develops and implements protocols for research program that include strategies and processes to ensure data security and provenance.Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke. Serves as an expert resource to multiple study teams/research program with regard to mapping dataflow. Predicts areas of vulnerability in the data flow plan.Determines areas where data provenance may be compromised and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement, as relevant. Oversees implementation of new technologies and ensures continuous evaluation of technology solutions throughout the research portfolio.

Science:
Assists with or contributes to the development of funding proposals. Using scientific proposals from the PI, develops research protocols. Uses expertise in research design to provide significant contribution to protocols or research proposals.

Study and Site Management:
Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies. Works with the CRU or departmental leadership to ensure that studies are closed according to best practices and guidelines.

Leadership:
Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with advances in the scientific area and considers the impact on the research program. Keeps self and team current with research updates by attending external offerings; applies learned material on the job. Plays key/leadership role on committees and workgroups. Navigates processes and people involved in Duke clinical research, demonstrates organizational awareness, and has the interpersonal skills necessary to get work done efficiently.Develops and implements solutions that work within the existing leadership or organizational structure. Demonstrates resilience and actively facilitates the research program through change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation within the research program. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns the activities of the research program team members to accomplish the study goals.

Special skills:
Communication and technology skills are a must for this role. They also will need a background or an understanding of radiology modalities.

Required Qualifications at this Level

Minimum Qualifications:

Education/Training:

Completion of an Associate's degree.< /p>

Experience:

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

Skills:

Can easily use computing software and web-based applications (e.g., Microsoft Office products and the electronic medical record). Ability to utilize interpersonal and communications kills to get work done effectively.

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Duke University 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 essential job 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.

Minimum Qualifications

Education

Completion of an Associate's degree

Experience

Work requires a minimum of six 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.