Job description

diversity employer


Occupational Summary This is a 100% sponsored funded position
Coordinate the day-to-day operations of multiple human subject clinical research studies conducted by principal investigators (PIs) of the Cancer Control & Population Sciences. Support the PIs through budget management, grant writing, protocol development, regulatory oversight and collaboration with internal and external partners. Perform study-specific regulatory & safety reporting processes across multiple studies in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), & study- specific protocols/plans & processes. Oversee the work of clinical research staff. Act as a liaison between research team and clinical staff.
Work Preformed
Study & Site Management- Obtain information for and coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Develop IRB documents and maintain study-level documentation for multiples studies.
Work closely with cardiology and oncology clinic staff to develop and implement feasible recruitment and intervention implementation plans. Work closely with internal analytics team to assist in the preparation of medical record data for analysis.
Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Assist with development of and maintenance of study budgets.
Prepare for, take part in, and potentially lead site initiation, monitoring, and closeout visits and document storage activities.
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.
Clinical Research Operations-Screen, schedule, consent, and collect adverse event information for participants in a variety of studies. Maintain subject level documentation, including documentation of consent in the electronic medical record. Prepare documents, equipment, or supplies for research visits. Conduct and document visits and protocol- specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies independently. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Evaluate processes to identify issues related to recruitment and retention rates.
Prepare for study monitoring or study audit visits. Assist with addressing and correcting findings.
Develop Institutional Review Board documents such as consent forms, protocols, and continuing reviews in a timely fashion. Maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
Collect, prepare, or process adverse event information per protocol, and provide input for adverse event reports. Complete and submit AE Reports, according to institution and sponsor-specific reporting requirements. Have familiarity with intellectual property rights, inventions patents, and technologies. As appropriate, understand regulations related to investigational products with sponsors. Coordinate with Duke Core services such as Investigational Drug Service (IDS), Biobank, etc. Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.).
Ethical & Participant Safety Considerations -Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority. Help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
May develop, or assist with the development of, documents related to safety and security.
Data Management & Informatics-Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Enter data accurately. Score tests and measures according to protocol and appropriate to role. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Assist with the development of data collection documents to standardize process. Detect issues related to data capture, collection or management; suggest solutions.
Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data.
Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to security of data and data provenance.
Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place (e.g., data use agreements, data transfer agreements, Investigational Device Exemptions (IDEs), etc.).
Scientific Concepts & Research Design- Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of or develop proposals or protocols; identify shortcomings of proposals and protocols.
Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims. May determine operational/statistical elements needed for conduct of clinical and translational studies.
Leadership & Professionalism- Encourage and support colleagues to complete project work. Assist research colleagues in identifying efficiencies and improving process. Actively network and encourage leadership for staff within a small work group. Successfully take part in or lead a committee, task force, or ad hoc group. Encourage career development by actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications.
Communication & Team Science- Prepare for and lead team meetings. Recognize when others need to be included in the conversation and escalate appropriately. Expand on the ideas of peers or team members.
And other work as assigned.
The above statements describe the general nature & level of work being performed. This is not intended to be an exhaustive list of all responsibilities & 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 & the types of duties & responsibilities that will be required of this position & shall not be construed as a declaration of the total specific duties & responsibilities.

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.


1.Completion of a Bachelor's degree. 2.Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination).

Preferences Master's level preferred. Prefer candidates who have IRB experience and at least 1 year managing research studies.

Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers). Must be able to work independently, manage competing priorities and be proactive in the work. Must have strong communication skills and the ability to work collaboratively across various projects and with diverse teams.

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: 6/17/2018
Application Due: 7/13/2018
Work Type: