Job description

diversity employer

GU Clincial Rsch

Occupational Summary
Lead day-to-day operations of clinical research studies for the Duke Cancer Institute (DCI) with the Oncology Clinical Research Unit (OncCRU) GU Research Team; perform a variety of complex duties involved in the collection, compilation, documentation, and analysis of clinical research data; lead others through navigating the clinical research environment. Oversee staff for clinical, data and regulatory compliance and implementation for team.

Work Performed

Clinical Trials Operations
Set up unit-wide systems and policies related to subject screening and subject level documentation. Provide oversight and training to the GU Team on subject screening and subject level documentation. 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 related to subject recruitment. Provide oversight to study team members who conduct and document consent of patients.
Conduct study visits independently. Serve as a resource and
trainer on the preparation and conduct of study visits, creation of SOPs, and implementation of operational plans.
Serve as an expert resource for study teams, DUHS procurement, billing and compliance for the proper handling of Investigational Product (IP). Create, optimize, and oversee systems to collect, prepare, process, ship, and maintain inventory of research specimens and train the team in these tasks. Oversee implementation of and compliance for handling, dispensing and documentation of IP for sponsored protocols. Understand regulations related to investigational products with sponsors. Coordinate with Duke Core services such as Investigational Drug Service (IDS), Biobank, etc.

Lead development of policies for monitoring and audits. Oversee the collection of adverse event (AE) information for the team and provide input for AE reports. Serve as a resource for institution and sponsor-specific reporting requirements (timelines and forms). Liaise with the DCI Safety Team on the final determination of safety event outcome.

Develop and provide oversight for IRB documents and communications.

Ethics and Participant Safety Considerations
Help staff and patients recognize the difference between clinical care and clinical management of research participants. Train team in the ethical conduct of research. Serve as the expert resource in the design of studies, ensure inclusion of safeguards to ensure ethical conduct and protect vulnerable populations. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.

Data Management and Informatics
Map protocol data flow, predict areas of vulnerability and provide solutions. Design ECRFs and EDCs to collect data according to protocol. Recommend and lead implementation of processes, policies, and systems to ensure data security and data provenance. Oversee the creation and use of queries, summaries, and reports. Develop and implement quality assurance systems for research data. Update QA SOPs. Oversee implementation of contracts and agreements within unit or department.

Scientific Concepts and Research Design
Conduct literature reviews. Collaborate with stakeholders (statistical, operational, etc.) to ensure adequate design, implementation and testing of study. Assess and determine solutions for operational shortcomings of proposals and protocols. Summarize and interpret study results, and determine application to future study procedures.

Leadership and Professionalism
Actively network and encourage staff leadership. Encourage career development by actively seeking out continuing education opportunities, participation in committees or ad hoc groups for self and team. Mentor staff. Establish and assign the activities to accomplish study goals.

Maintain training requirements and proactively ensure team's compliance with training requirements. Create strategies to enhance cultural diversity and cultural competency in the design and conduct of clinical research.

Study and Site Management
Develop and oversee processes to determine sponsorship, supervision or participation in trials. Oversee processes for research resources and finances. Provide leadership and training for compliance with institutional requirements and policies. Work with sponsors and study teams on required sponsor training. Document and develop systems for process flows, training manuals, and standard operating procedures. Develop and implement closeout procedures.

Communication and Team Science
Act as an expert resource to junior staff. Liaise with sponsors, subcontractors, or vendors. Prepare for and lead team meetings. Mentor junior staff.

Nursing Activities
Plan, provide, supervise and document professional nursing care for patients in accordance with physician orders and established policies and procedures. Use professional nursing judgment when conducting nursing research activities to patients. Clinical responsibilities may include Ambulatory Medication Administration, Adult Medication, Adult Chemotherapy Administration, Adult Dysrhythmia Review, and Basic Dysrhythmia Review.
Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources. Participate in the identification of clinical or operational performance improvement opportunities and in performance improvement activities.

Complete 18 hours of Continuing Education per year. Maintain hospital and unit specific training requirements.
Other work as assigned.

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.

Requisition Number


Duke Entity

Job Code

Job Family Level


Full Time / Part Time

Regular / Temporary


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.


Work requires graduation from an accredited BSN or Associate's Degree in Nursing or Nursing Diploma program.All registered nurses without a Bachelor's degree in Nursing (or higher)will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five years of their start date.Must have current or compact RN licensure in the state of North Carolina. BLS required.


Twelve months of appropriate clinical experience is required, plus four years of research experience. For those with an associate's degree, a minimum of six years of research experience is required.

Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers). GU Oncology research experience is preferred.
The preferred candidate will have Oncology experience, training, education.

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.





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Job No:
Posted: 3/21/2018
Application Due: 5/20/2018
Work Type: