REGULATORY COORD

Job description


diversity employer



REGULATORY COORD
Brain Tumor Clinical Rsch

Occupational Summary
Perform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute's [DCI] Brain Tumor Clinical Research Program [BTC]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.
Work Preformed

Operations, Study and Site Management - 70% Effort

Develop and submit Institutional Review Board [IRB] documents such as consent forms, protocols, continuing review progress reports, memos to file, and supporting documents. Maintain study level documentation, including regulatory binders and e-binders. Submit initial new studies, amendments, continuing reviews, deviations, and safety reports.
Maintain study compliance according to institutional requirements, protocols and other applicable policies, such as NIH Public Access policy, ClinicalTrials.gov, and Research Data Security Plans.
Oversee maintenance of Delegation of Authority Logs, training of key personnel on study specific duties, financial disclosure forms, FDA Forms 1572, and other regulatory documentation.
Potentially, submit and maintain Investigational New Drugs (INDs).
Work closely with study sponsors and internal committees and offices on regulatory and safety issues.
Prepare for study monitoring and study audit visits. Assist with addressing and correcting findings from study monitoring and study audit visits.
Complete and submit Adverse Events Reports, according to federal, institutional, and sponsor-specific reporting requirements [timelines and forms].

Communication - 15% Effort

Collaborate and communicate with other study personnel as required, such as: IRB, Cancer Protocol Committee, other Duke Sub-committees, and sponsors. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls, and questions. Refer more complex questions and escalate issues to others as appropriate.

Ethics - 15% Effort
Summarize and clarify for study teams the professional guidelines and code of ethics related to regulatory and safety issues in the conduct of clinical research.
Know and follow policies, standard operating procedures (SOPs), regulations, and protocol requirements that govern clinical research. Maintain Duke and project specific training and certification requirements.

Leadership

Actively network. Provide leadership within the team. Actively and proactively participate in team meetings, committees, task forces and ad hoc groups.
Encourage career development by actively seeking out continuing education opportunities.
Serve as an expert resource for colleagues and teammates. Mentor staff, including those in the same job title. Support colleagues in their project work; encourage completion.

And other work as assigned.

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.


Requisition Number
401532372

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1219 REGULATORY COORD

Job Family Level
52

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
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.

Education

1.Completion of a bachelor's degree. 2.Completion of an Associates degree plus a minimum of two years of research and/or regulatory experience.

Skills

Must have strong organizational skills, be able to effectively prioritize competing projects, and have solid written communication skills.

Preferences

The preferred candidate will have oncology or research experience, training, and education.


Auto req ID

108044BR

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.

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Job No:
Posted: 12/15/2018
Application Due: 2/13/2019
Work Type:
Salary: