CLINICAL RESEARCH COORDINATOR - ABDOMINAL TRANSPLANT
CLINICAL RESEARCH COORDINATOR - ABDOMINAL TRANSPLANT
1.Clinical research operations. Screen, schedule, consent, andcollectadverse event informationfor participants in a variety of studies. Maintain subject leveldocumentation, includingdocumentation 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.Develop or provide input for Institutional Review Board documents such as consent forms, protocols, and continuing reviews in a timely fashion. Maintain or collaborate to maintain appropriate study-level documentation including regulatory binders,enrollment logs, patient registration in the system of record, etc.Assist with management of Investigational Products (IP )including arrival, storage, handling,requesting requisitions, inventory, reordering, drug accountability,reconciliation, and destruction.May be responsible for determining the best methods for handling IP forInvestigator-initiatedprotocols, or coordinating with investigational pharmacies asnecessary.Collect, prepare, or process adverse event information per protocol,and provide input for adverseevent reports. May complete and submit Adverse Events Reports,according to institution andsponsor-specific prompt reporting requirements (timelines and forms).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 DrugApplications, etc.).
2.Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research with vulnerable populations. Train junior staff in the ethical conduct of research, dealing with vulnerable populations, and provide guidance in strategies used to maintain safety.May develop or assist with the development of documents related to safety and security (e.g.,Research Data Security Plans, Data Safety Monitoring Plans, Conflict of Interest). Coordinate or assist with the coordination of efforts of external monitoring boards.Communicate to research participants, both orally and written, the difference between clinical activities and research activities, and the risks and benefits of study participation, in all study documents and research participant communications. May recognize when patients are having difficulties with this distinction. May make recommendations regarding how to improve communications to help patients and staff understand the distinction.
3.Data management and 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 torole.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. May independently design ECRFs and EDCs to collect data and select methods of data capture and discuss advantages and disadvantages of each.Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with developmentof, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes.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. Map protocol data flow. Predict areas of vulnerability for a protocol's data flow plan. Determine areas where data provenance may be compromised. May be responsible for determining 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.).
4.Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. 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.
5.Leadership and 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. Encourage career development by actively seek out continuing education opportunities for self and study team members.Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff,including other Clinical Research Coordinators. Employ escalation and performance plans as needed. May be responsible for providing constructive feedback to team members. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Summarize and clarify for study teams, the professional guidelines and code ofethics related to the conduct of clinical research. May be responsiblefor identifying potential problems and risks to the participant, study, investigator, team,sponsor, and institution.
6. Study and site management. Participate in sponsor-required training.Obtain information for orcoordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately.Prepare for, take part in, and potentially lead site initiation,monitoring, and closeout visits and document storage activities. Collect information to determine feasibility, recruitment and retention strategies.Maintain study's compliance with institutional requirements and other policies (e.g., NIH PublicAccess policy, ct.gov, Research Data Security Plans, Social Mediapolicy, etc.). Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
7. Communication and team science. Prepare for and lead team meetings.Recognize when others need to be brought into the conversation and escalate appropriately.
1201 CLINICAL RESEARCH COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
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1.Completion of a Bachelor's degree2.Completion of an Associates degree plus a minimum of two yearsrelevant experience (e.g., research, clinical, interaction with studypopulation, program coordination)
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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.