Clinical Research Coordinator, Duke Early Phase Research Unit
DUKE EARLY PHASE RESEARCH UNIT
Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Early Phase Clinical Research Unit; perform avariety of duties involved inthe collection, compilation, documentation, and analysis of clinical research data. May oversee thework of junior staff.
- Clinical research operations. Screen, schedule, consent, and collect adverse events (AE)information for participants in a variety of studies. Main duties will be to dedicated to the baseline project. Maintain subject level documentation, including documentation 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 tostudy protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs)for all types of studies in dependently. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Evaluate processes to identifyissues related to recruitment and retention rates. May provide training to personnel.Collect, prepare, process, ship, and maintain inventory of researchspecimens and train others inthese tasks; improve systems related to specimen handling.Prepare for study monitoring or study audit visits. Assist with addressing and correcting findings.Develop or provide input for IRB documents. Maintain, or collaborate to maintain, appropriate study-level documentation.Assist with management of Investigational Products (IP). Employ the required system for handling,dispensing and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling IP for Investigator-initiated protocols,or coordinating within vestigational pharmacies as necessary. Maintain appropriate documentation. Track IPcompliance at the protocol-and subject level.Collect, prepare, or process adverse event information per protocol,and provide input for adverse event reports. May complete and submit AE Reports, according to institution and sponsor-specific reporting requirements.Have familiarity with intellectual property rights, inventions patents,and technologies. As appropriate, understand regulations related to investigational products with sponsors. Coordinate with Duke core services. Recognize the need for agreements (e.g.,Material Transfer Agreements,Investigational New Drug Applications, etc.).
- Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. Train juniorstaff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.May develop, or assist with the development of, documents related to safety and security.Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation.
- Data management and informatics. Use and train others in Electronic Data Capture (EDC)systems, technologies, and software necessary for study operations.Score tests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments. Detect issues related to data capture,collection or management; suggest solutions.Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reportsto monitor the quality ofdata. May develop QA processes and oversee the creation and use ofqueries, summaries, andreports for quality assurance purposes. May be responsible forrecognizing trends related to dataqualityand escalating as appropriate.Use required processes, policies, and systems to ensure data securityand data provenance.Recognize and report vulnerabilities related to security of physicaland electronic data; suggestand implement solutions to vulnerabilities related to security of dataand data provenance.Map protocol data flow. Predict areas of vulnerability for aprotocol???s data flow plan. Determineareas where data provenance may be compromised and develop solutions.Recognize when dataagreements or special regulatory requirements are necessary; mayassemble the necessaryparties to ensure that all agreements are inplace.
- Scientific concepts and research design. Understand and train othersin the basic concepts ofstudy design.Independently conduct literature reviews. Assist with thedevelopment of, or develop,proposals or protocols; identify shortcomings of proposals andprotocols.Identify various stakeholders (statistical, operational, etc.) toensure adequate design,implementation, and testing of study aims. May determineoperational/statistical elements neededfor conduct of clinical and translational studies.
- Leadership and professionalism. Assist research colleagues inidentifying efficiencies andimproving process. Successfully take part in or lead a committee ortask force. Actively seek outcontinuing education opportunities for self and study team members.Participate in or leadscientific presentations and publications.Assign, review, and train others in various work responsibilities.Serve as a mentorto junior staff,including other CRCs. Employ escalation and performance plans asneeded.Recognize and employ the professional guidelines and code of ethicsrelated to the conduct ofclinical research; summarize and clarify for study teams. May beresponsible for identifyingpotential problems and risks to the participants, study, andinstitution.
- Study and site management. Participate in sponsor-required training.Obtain information for orcoordinate operational plans for multiple research studies. Developprotocol-specific systems anddocuments including process flows, training manuals, SOPs, and CRFs.Ensure participant careexpenses have appropriate financial routing. Monitor financial studymilestones and reportappropriately. Coordinate with financial teams, PRMO, etc. Assist withstudybudgets.Prepare for, take part in,and potentially lead site initiation,monitoring, closeout visits, anddocument storage activities.Collect information to determine feasibility, recruitment and retentionstrategies. May makerecommendations to investigators and oversight organization(s).Maintain compliance withinstitutional requirements and policies. Oversee maintenance ofDelegation of Authority Logs andtraining of KP on study specificduties.
Requisition Number 401479514
Duke Entity MEDICAL CENTER
Job Code 1201 CLINICAL RESEARCH COORDINATOR
Job Family Level 52
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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- Completion of a Bachelor's degree
- Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)
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