Social & Community Psychiatry

Job Description

Occupational Summary

Operations:

Screen participants for all studies independently. Maintain subject level documentation for all studies independently Schedule participants and conduct visits for minimal risk studies independently. Collect, prepare, process, ship, and maintain inventory of research specimens. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. 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.

Independently conducts and documents consent for participants in all studies, including those that are complex in nature/clinically relevant and/or require access to the EHR for documentation. May train or oversee others.  Collect, prepare or process adverse event information independently Complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) under supervision. Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.

Ethics:

Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications. 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.  Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial 

Data:

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 (CRFs and eCRFs) accurately and according to protocol. Use required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Run summaries and reports on existing data Assist with development of and follow SOPs for data quality assurance.

Science:

Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.

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. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate. Assist with study budgets. Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, 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 meetings independently Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. 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. Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.

Job Code 1201 CLINICAL RESEARCH COORDINATOR
Requisition Number 401601493
Location Durham
Duke Entity MEDICAL CENTER
Job Family Level 52
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

Completion of an Associate's degree

Experience

Work requires a minimum of two years of relevant research experience. ABachelor's degree may substitute for 2 years required experience.

Auto req ID

113928BR