diversity employer


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 the work of junior staff.

Type of Research
Phased clinical trials and registries with pediatric population in Nephrology, Neurology and potential for other divisions with pediatric population. Serve as primary coordinator with the ability to cross cover others as back-up coordinator when needed.

Special Skills
Experienced CRC with solid background in managing multiple clinical research projects & ability to interact professionally with other team members.

Work Performed

1.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 andprotocol-specific testing/interviews according to study protocol,operational plans of clinicaldepartments, and Standard Operating Procedures (SOPs) for all types ofstudies independently.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 collaborate tomaintain, appropriatestudy-level documentation.Assist with management of Investigational Products (IP). Employ therequired system for handling,dispensing and documentation of IP for sponsored protocols. May beresponsible for determiningthebest methods for handling IP for Investigator-initiated protocols, orcoordinating withinvestigational pharmacies as necessary. Maintain appropriatedocumentation. Track IPcompliance atthe 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.).

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 Data Capture (EDC) systems, technologies, and softwarenecessary for studyoperations.Score tests, enter data, and complete Case Report Forms accurately andaccording to protocol.Assistwith the development of, or develop, data collection documents andinstruments. Detect issuesrelated to data capture, collection or management; suggest solutions.Investigate incomplete, inaccurate, or missing data/documents to ensureaccuracy andcompleteness ofdata; follow and develop, or assist with development of, SOPs for dataquality assurance. Adheretoprocesses and run queries, summaries, and reports to monitor thequality of data. May develop QAprocesses and oversee the creation and use of queries, summaries, andreports for qualityassurancepurposes. May be responsible for recognizing trends related to dataquality and escalating asappropriate.Map protocol data flow. Predict areas of vulnerability for a protocoldata flow plan. Determineareas where data provenance may be compromised and develop solutions.Recognize when data agreements or special regulatory requirements arenecessary; mayassemble thenecessary parties to ensure that all agreements are in place.

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 neededforconduct 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 juniorstaff, 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, and institution.

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, andCRFs.Ensure participant care expenses have appropriate financial routing.Monitor financial studymilestones and report appropriately. 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 oversightorganization(s).Maintain compliance with institutional requirements and policies.Oversee maintenance ofDelegationof Authority Logs and training of KP on study specific duties.

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 be responsible for taking action when communication has stalled with sites, CROs, sponsors.Maintain Duke and project specific training requirements. Develop solutions to proactively ensure study team members' compliance with training requirements.Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical 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.


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