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RESEARCH PROGRAM LEADER

Job description


diversity employer



RESEARCH PROGRAM LEADER
CFM - Research and Education

Operations:

Provide oversight and training to entire unit or department with regards to subject screening. Set up unit-wide systems, policies related to subject screening. Provide oversight and training to entire unit or department with regards to maintaining subject level documentation. Set up unit-wide systems, policies related to subject level documentation.

May conduct study visits independently. Serve as a unit/departmental resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans. Create, optimize, and oversee systems to collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.

Train staff to maintain exemplary documentation including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc.

Oversee maintenance of subject level documentation. Participate in or lead development of policies and guidance related to subject recruitment. Serve as an expert resource across unit or department. Provide oversight to study team members who conduct and document consent for participants in a variety of studies. Serve as an expert resource with regard to conduct and documentation of consent.

Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings.

Oversee the collection of adverse event information for an entire unit or department Provide input for AE reports. Serve as a resource to junior staff as well as the unit, department, or division staff with regard to institution and sponsor-specific prompt reporting requirements (timelines and forms).

Liaise with contact for final determination of safety event outcome. Serve as a unit, department, or division resource for development of IRB documents and for guidance on IRB communications,

Ethics:

Serve as a resource to unit or department to help staff and patients recognize the difference between clinical care and clinical management of research participants Provide unit, division or department-wide training in ethical conduct of research.

Serve as expert resource to study teams as they design studies, so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Serve as a resource for development and implementation of RDSPs and DSMPs and COIs across multiple studies or study teams.

Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.

Requisition Number
401505398

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1280 RESEARCH PROGRAM LEADER

Job Family Level
68

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 plus a minimum of four years of research experience. 2.Completion of a master's degree plus a minimum of two years of research experience.

Auto req ID

105857BR

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.

PI104859060

 

 

 

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Job No:
Posted: 10/12/2018
Application Due: 12/11/2018
Work Type:
Salary: