CLINICAL TRIALS PROJECT LEADER I
CLINICAL TRIALS PROJECT LEADER I
Under the direction of the Director/Associate Director of Regulatory Affairs, this position includes providing guidance and assistance to investigators and study teams who need FDA oversight for their research projects. This includes working on Initial Investigational New Drug or Investigational Device Exemption applications, requests for meetings with FDA and supporting documentation, and ensuring compliant maintenance of effective IND and IDEs.
Other duties will include training and assistance for investigational staff.
The Project Leader will liaise with several groups, including principal investigators, research fellows and regulatory coordinators. He/she will also serve as a liaison and provide operational and compliance guidance to these groups. The PL will also provide guidance and support of electronic submissions.
For this position, there will be special priority placed on supporting the regulatory needs of the Duke Brain Tumor Immunotherapy Program (BTIP) within the Duke Department of Neurosurgery. This will include: attendance at weekly BTIP meetings, regular meetings with key BTIP personnel and prioritizing BTIP projects. This support will also include providing regulatory support for the Molecular Products and Cellular Therapy (MPACT) Manufacturing Facility.
Authoring/editing the submission of initial IND/IDEs; maintenance of INDs/IDEs (including amendments, annual reports and safety reporting); assessment of exemption for INDs with marketed drugs; assessment whether IDEs are required for device studies, production of electronic submissions in the Common Technical Document format, and preparation of FDA meeting request letters briefing documents. Act as an FDA contact for Duke investigators in order to help resolve issues in a timely manner. Perform a variety of duties involved in the organization, documentation and compilation of regulatory documents.
With direction, provide regulatory advice to Duke sponsor-investigators and their research teams by explaining and interpreting regulations and encouraging adherence to FDA guidance. Work to identify potential problems and/or inconsistencies and make corrections as appropriate. Encourage best practices among all Duke investigators.
Along with other ORAQ staff and with direction, work on ORAQ initiatives in the education, operations, or collaboration area.
Support the DUHS IRB by reviewing PI-initiated research studies and evaluating them for regulatory issues.
Attend regulatory affairs training courses and become familiar with appropriate regulations and guidance documents in order to understand the statutes in order to provide direction to investigators desiring regulatory support.
Work with the other ORAQ staff to create and maintain best practices workshops related to regulatory issues including INDs and IDEs. Provide training and support material for all regulatory documents listed above.
Work with the other ORAQ staff to mentor other professionals through the ORAQ Regulatory Affairs Training Program.
Assist with new and ongoing research projects related to regulatory issues, with the objective to publish the research findings.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification.
1635 CLINICAL TRIALS PROJECT LEADER I
Job Family Level
Full Time / Part Time
Regular / Temporary
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.
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant(PA) or Pharmacist plus two years of healthcare experience, or one of the following equivalents:1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associate's degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or 2. Completion of a Master's degree in Public Health, Health Administration or a related area with one year directly related Clinical trials research experience; or 3. Completion of a Bachelor's degree plus a minimum of three years directly related experience in clinical trials research; or 4. Completion of a Bachelor's degree plus a minimum of four years closely related research experience.**State of North Carolina license may be required.**
None required beyond that described above.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Preferred Education: PhD in Biology, Chemistry or Life Sciences or equivalent doctorate (e.g. MD, PharmD).
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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.