Durham, NC
Apr 25, 2017
Institution Type
Four-Year Institution

DCRI Duke Clinical Research Unit

Occupational Summary

Participate in or lead day-to-day operations of clinical researchstudies conducted by principalinvestigator(s) at Duke Medicine; perform a variety of duties involvedin the collection, compilation,documentation, and analysis of clinical research data. May oversee thework of junior staff.Work PerformedClinical research operations. Screen, schedule, consent, andcollect adverse events (AE) information for participants in a varietyof studies.

Maintain subject level documentation, including documentation of consent in theelectronic medical record. Prepare documents, 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.

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 withaddressing and correcting findings.Develop or provide input for IRB documents. Maintain, or collaborate tomaintain, appropriatestudy-level documentation.Assist with management of Investigational Products (IP). Employ the required 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.Collect, prepare, or process adverse event information per protocol,and provide input for adverseevent reports. May complete and submit AE Reports, according toinstitution and sponsor-specificreportingrequirements.Have familiarity with intellectual property rights, inventions patents,and technologies. Asappropriate, understand regulations related to investigational productswith sponsors. Coordinatewith 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 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 Data Capture (EDC) systems, technologies, and softwarenecessary for study operations.

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 data qualityassurance. 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 data provenance.

Map protocol data flow. Predict areas of vulnerability for a protocol#sdata flow plan. Determineareas where data provenance may be compromised and develop solutions.Recognize when data agreements or special regulatory requirements arenecessary; mayassemble the necessary parties 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. Serveas 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.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.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 be responsible fortakingaction when communication has stalled with sites, CROs, sponsors.Maintain Duke andproject specific training requirements. Develop solutions toproactively ensure study teammembers' compliance with training requirements.Evaluate the need for cultural diversity and cultural competency in thedesign and conduct ofclinical research. Make recommendations to investigative team.

Requisition Number


Duke Entity

Job Code

Job Family Level


Full Time / Part Time

Regular / Temporary


Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual'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 mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.


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)

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.


Similar jobs

Similar jobs