RESEARCH PROGRAM LEADER, SR - PEDS

Location
Durham, NC
Posted
Jun 14, 2018
Institution Type
Four-Year Institution

diversity employer



RESEARCH PROGRAM LEADER, SR - PEDS
Pediatrics-SBRU

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. Create unit-wide (and collaborate to create institution-wide) policies and guidances regarding conduct of study visits.
  • Create unit-wide (and collaborate to create institution-wide) policies and guidances related to research specimens.
  • Participate in or lead development of policies and guidances related to the management of IP Participate in or lead development of policies and guidances related to study level documentation.
  • Participate in or lead development of policies and guidancesrelated to subject recruitment.
  • Serve as an expert resource across unit or department.
  • Participate in or lead development of policies and guidances related to consent.
  • Serve as an expert resource across unit or department. Participate in or lead development of policies and guidances related to monitoring and audits.
  • Serve as an expert resource when addressing and correcting 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.
  • Possess thorough understanding of intellectual property rights, inventions, patents, and technologies.
  • Coordinate with Duke core services such as Investigational Drug Service, Biobank, etc.
  • Coordinate necessary agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.).
  • Serve as a unit, department, or division resource for development of IRB documents and for guidance on IRB communications

Data:
  • Predict areas of vulnerability for data flow for multiple studies or across a unit, department or division.
  • Design data flow plans that include elements related to data capture, storage, management, quality, and preparation for analysis; implement across multiple studies or at unit, department or division level.
  • Serve as unit/departmental/institutional resource on ECRFs, EDCSs, technologies, and software to ensure highest quality data collection and capture
  • May assist with development of, or develop, guidances and policies related to research data provenance and security.
  • Serve as unit/departmental resource to others regarding data provenance and security.
  • Develop system/framework for QA processes for multiple studies or for entire unit.
  • Develop unit/department - wide quality assurance systems for research data; oversee implementation.
  • Oversee implementation of contracts and agreements within unit or department

Science:
  • Conduct and synthesize literature reviews independently
  • Collaborate with various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation and testing of study aims Develop proposals or protocols independently.
  • Assess and determine solutions for operational shortcomings of proposals and protocols.
  • Summarize and interpret study results, and determine application to future study procedures.

Position is 100% grant-funded

Requisition Number
401434544

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1281 RESEARCH PROGRAM LEADER, SR

Job Family Level
69

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

Work requires one of the following: 1.Completion of a bachelor's degree plus, a minimum of eight years of research experience 2.Completion of a master's degree, plus a minimum of six years of research experience 3.Completion of a doctoral degree, plus a minimum of four years of research experience

Auto req ID

101720BR

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.

PI102926263

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