CLINICAL RESEARCH COORDINATOR
CLINICAL RESEARCH COORDINATOR
Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff.
Operations 10%: 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 maintaininventory of research specimens and train others in these tasks. Collaborate to 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. 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. Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
Ethics 5%: 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
Data 70%: 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, andsoftware 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. Recognize when data agreements are necessary
Leadership 5%: Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. May serve as mentor to other staff. 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. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
Study and Site Management 5%: Make recommendations to investigators and oversight organization regarding 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/closeout visits as directed. 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 5%: Serve as primary liaison with single sponsor, subcontractor, or vendors. Communicate concerns clearly and in a professional manner. Prepare for and lead team meetings. Recognize when others need to be brought into the conversation and escalate appropriately. Expand on the ideas of peers or team members. Take an active role in including others in decision-making. Knowledge, Skills and Abilities Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
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 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.
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.