Job description

diversity employer

GI Clinical Rsch

This isThtio
TThis is a 100% sponsored funded position.

Occupational Summary
Provide leadership and coordination in the conduct of multiple, complex oncology clinical research studies and trials including Investigational Products (IP) for the Duke Cancer Institute's (DCI) GI Research Program. The Oncology Clinical Research Unit (OncCRU) oversees the conduct of research. Perform a variety of complex duties involved in the collection, compilation, documentation, and analysis of clinical research.

Work Preformed
Employ strategies to maintain recruitment and retention rates, and assist participants with individual needs. Evaluate processes to identify issues related to recruitment and retention rates.
Work closely with the Principal Investigator (PI) and study team to recruit and enroll participants for studies. Conduct and document consent for study participants. Schedule participants and conduct visits for studies; conduct and document visits and protocol-specific testing.
Maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
Create, optimize, and oversee systems to collect, prepare, process, ship, and maintain inventory of research specimens.
Assist with addressing and correcting findings from study monitoring and study audit visits. Collect, prepare or process adverse event information independently. Complete and submit AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms).
Provide input for Institutional Review Board (IRB) documents such as consent forms, protocols, and continuing reviews.

Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria. Recognize when patients are having difficulties with this distinction. Make recommendations regarding how to improve communications to help patients and staff understand the distinction.
Assist with the development of Conflict of Interest (COI), Data Safety Monitoring Plans (DSMPs), and Research Data Security Plans (RDSPs). Assist with the coordination of external monitoring boards.

Use Electronic Data Capture (EDC) systems and enter data accurately. Detect issues related to data capture, collection or management and suggest solutions.
Follow SOPS for data QA; comply with required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. Assist in investigating incomplete, inaccurate or missing data and documents to ensure accuracy and completeness of data.

Summarize study results.

Actively network and encourage leadership for staff within a small work group. Actively and proactively participate in team meetings, committees, task forces and ad hoc groups. Encourage career development by actively seeking out continuing education opportunities. Participate in scientific presentations and publications.
Serve as an expert resource, mentor and train staff, including others with my title. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
Maintain Duke and project specific training requirements.

Study and Site Management
Collect information to determine appropriate feasibility, recruitment and retention strategies.
Follow procedures and documentation of study payment in a timely fashion. Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate. Assist with study budgets and closeouts.
Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy,, Research Data Security Plans, Social Media policy, etc.). Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Take part in site initiation and closeout visits as directed.
Recognize components of operational plans and be able to obtain information needed to develop the plan. Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Prepare for closeout and document storage.

Serve as primary liaison with sponsors, study personnel and PI for assigned studies. Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.
Communicate concerns clearly and in a professional manner. Respond timely to emails, phone calls and questions. Refer more complex questions to others as appropriate.

Actively participate in study team meetings.

Clinical Responsibilities
  • Ambulatory Medication Administration
  • Medication management to include patient education on specific study medications and side effects
  • Adult Chemotherapy Administration
  • Basic Dysrhythmia Review
  • Review clinical laboratory results
  • Assess patient to recognize adverse events, check patient compliance, provide education and appropriate interventions as guided by PI.
  • Interact effectively with medical team.
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 Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, gender, gender expression, genderidentity, 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 robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.


Work requires graduation from an accredited BSN or Associate's Degree inNursing 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 twoyears of their start date and to complete the program within five yearsof their start date.Must have current or compact RN licensure in the state of NorthCarolina. BLS required.


Twelve months of appropriate clinical nursing experience is required.

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: 10/31/2018
Application Due: 12/6/2018
Work Type: