CLINICAL RESEARCH COORDINATOR
CLINICAL RESEARCH COORDINATOR
Medicine-Rheumatology and Immunology
Screen participants for minimal risk studies. May screen participants for studies with greater than minimal risk, under supervision. 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. Describe the various steps involved in handling IP. Assist with management of Investigational Products (IP) including arrival, storage, handling including requesting requisitions, inventory, and reordering 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. 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 Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) under supervision. Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
Recognize when patients are having difficulties with this distinction. Make recommendations regarding how to improve communications to help patients and staff understand the distinction. 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
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. Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Follow SOPs for data QA. Recognize when data agreements are necessary
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. Prepare items for site initiation visits. Participate in sponsor required training Take part in or lead closeout and document storage activities
Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. 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.
Type of Research
This person will work in Rheumatology and Immunology.
1201 CLINICAL RESEARCH COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
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 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.
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).
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.