Occ SummaryParticipate in or lead day-to-day operations of clinical researchstudies conducted by principalinvestigator(s) atDuke Medicine; perform a variety of duties involvedin the collection, compilation,documentation, and analysis of clinical research data. May oversee thework of junior staff.Work Performed1.Clinical research operations. Screen, schedule, consent, andcollect adverse events (AE) information for participants in a varietyof studies. Maintain subjectlevel documentation, including documentation of consent in theelectronic medical record. Preparedocuments, equipment, or supplies for research visits. Conduct anddocument visits and protocol-specific testing/interviews according to study protocol, operationalplans of clinical departments,and Standard Operating Procedures (SOPs) for all types of studiesindependently. Employstrategies to maintain recruitment and retention rates,and to assistparticipants with individualneeds. Evaluate processes to identify issues related to recruitment andretention rates. Mayprovide 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 withaddressing and correcting findings.Develop or provide input for IRB documents. Maintain, or collaboratetomaintain, appropriatestudy-level documentation.Assist with management of Investigational Products (IP). Employ therequired system forhandling, dispensing and documentation of IP for sponsored protocols.May be responsible fordetermining the best methods for handling IP for Investigator-initiatedprotocols, or coordinatingwith investigational pharmacies as necessary. Maintain appropriatedocumentation. Track IPcompliance at the protocol-and subject level.2.Ethical and participant safety considerations. Maintainfamiliarity with the ethical conduct of research and safeguards neededwhen conducting research.Train junior staff in the ethical conduct of research. May help in thedesign of studies so theyinclude specific safeguards to ensure ethical conduct and protectvulnerable populations.May develop, or assist with the development of, documents related tosafety and security.Communicate to research participants the difference between clinicalactivities and researchactivities, and the risks and benefits of study participation.3.Data management and informatics. Use and train others inElectronic DataCapture (EDC) systems, technologies, and softwarenecessary for studyoperations. Score tests, enter data, and complete Case Report Formsaccurately and according toprotocol. Assist with the development of, or develop, data collectiondocuments and instruments.Detect issues related to data capture, collection or management;suggest solutions.Investigate incomplete, inaccurate, or missing data/documents to ensureaccuracy andcompleteness of data; follow and develop, or assist with developmentof, SOPs for dataqualityassurance. 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 dataquality and 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 dataprovenance.4.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.5.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 mentor to 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.6.Study and site management. Participate in sponsor-requiredtraining. Obtain information for or coordinate operational plans formultiple research studies.Develop protocol-specific systems and documents including processflows, training manuals,SOPs, and CRFs.Ensure participant care expenses have appropriate financial routing.Monitor financial studymilestones and report appropriately. Coordinate with financial teams,PRMO, etc. Assist withstudy budgets.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 oversightorganization(s).Maintain compliance with institutional requirements and policies.Oversee maintenance ofDelegation of Authority Logs and training of KP on study specificduties.7.Communication and team science. Prepare for and lead teammeetings. Take an active role in including others in decision-making,and escalate issuesappropriately.Communicate with sponsors, subcontractors, or vendors. May beresponsible for taking actionwhen communication has stalled with sites, CROs, sponsors.Maintain Duke and project specific training requirements. Developsolutions to proactively ensurestudy team members' compliance with training requirements.Evaluate the need for cultural diversity and cultural competency in thedesign and conduct ofclinical research. Make recommendations toinvestigative team.Knowledge, Skills and AbilitiesCan easily use computing software and web-based applications (e.g.,Microsoft Office productsand internet browsers).