Operations:

Screen participants, schedule participants and conduct study visits, maintain subject level documentation, for all studies independently. Collect, prepare, process, ship, and maintain inventory of research specimens. Assist with management of IP, including handling, dispensing and documentation. Track IP compliance at the protocol-and subject level. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Evaluate processes to identify issues related to recruitment and retention rates. Conduct and document consent for participants in a variety of studies independently. 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 independently. Coordinate with Duke core services such as Investigational Drug Service (IDS), Biobank, etc.  Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
 
Ethics:

Make recommendations regarding how to improve communications to help patients and staff understand the distinction between research and clinical care. Be familiar 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. Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs).  Assist with the coordination of efforts of external monitoring boards. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial.
 
Data:

Map protocol data flow. Predict areas of vulnerability for a protocol's data flow plan. Determine areas where data provenance may be compromised. Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance.  Enter data accurately.  Score tests and measures according to protocol, and appropriate to role. Complete paper and electronic Case Report Forms accurately and according to protocol. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Run summaries and reports on existing data Follow SOPs for data QA. Recognize when data agreements are necessary.
 
Science:

Be able to conduct literature reviews independently 

Leadership:

Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process.  Recognize and employ 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. Ensure participant care expenses have appropriate financial routing in a timely manner. Maintain study's compliance with institutional requirements and other policies. Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Take part in site initiation and closeout meetings independently. Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Coordinate operational plans for multiple research studies. Take part in or lead closeout and document storage activities.
 
Communication:

Serve as primary liaison with single sponsor, subcontractor, or vendors.  Communicate concerns clearly and in a professional manner. Participate in study team meetings. Respond to routine questions related to study protocol and refer more complex questions to others as appropriate.  
 
Type of Research

This position will be working directly with a PI on their research studies occurring at both Duke and the VA hospital. This position will be part-time for about 6 weeks while being trained and will be increased to full time after that. 

Location Durham

Duke Entity MEDICAL CENTER

Job Family Level 52

Full Time / Part Time PART 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.
2. Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination).

Special Skills

The ideal candidate will have some general research knowledge and be interested in the process. This candidate should be interested in being involved with the studies and part of the team. General laboratory skills involving blood processing and phlebotomy skills would be a benefit.