CLINICAL RESEARCH ASSOCIATE II
CLINICAL RESEARCH ASSOCIATE II
DCRI - Site Support & Management
Primary Responsibilities and Tasks:No. Position Responsibilities & Key Tasks Percentage of Time (Optional)1.Oversee and review routine and moderately complex site activities, withminimal tono guidance,through monitoring activities, including on-site visits and/or in-houseassessments, includingtelephone contact, and other technologies according to thetrial-specific monitoring plan to assessprotocol, regulatory, and SOP compliance with some guidance from anexperiencedCRA or aclinicaltrial lead.a. May travel up to 80% to perform on-site monitoring visits, includingsite selection,initiation,periodic, and close out visits. Perform or assist with unexpected sitevisits as directed. Schedulesite visits according to DCRI travel policy and trial-specificguidelines while effectively usingcost and time saving efficiencies.b. Independently perform monitoring activities for multiple sites andpossibly multipleprojects,identifying and reporting deviations from regulations and SOPs. Assessprotocol and regulatorycompliance, including but not limited to source document verification,informed consent processandhuman subject protection, data integrity, drug accountability andcompliance, and review ofinvestigator and regulatory files.c. Assess adequacy of site personnel and facilities for studyconduct.d. Provide study training and guidance to designated site personnel forconductingstudies inaccordance with the protocol, SOPs, trial specific procedures andapplicable regulations. Identifysituations that may affect subject safety or data integrity and retrainsite personnel accordingly.e. Identify action items and discuss with appropriate site personnel.Communicateroutine andunusual findings to trial supervisor. Document ongoing follow-up andresolution of issues.Recognizeongoing action items and coach site personnel to improve theirperformance.f. Assist sites with preparation for planned and unannounced auditswith someguidance.g. Perform trial supervisory activities as directed by trial projectleader with approval oflinemanager.2. Independently document routine site management and clinicalmonitoring activities,sitecommunication, and trial related activities. Document complex sitemanagement and clinicalmonitoring activities, site communication, and trial related activitieswith minimal to no guidance.Utilize monitoring tools and trial documents, recommend revisions toimprove efficiencies ofmonitoring tools, trial documents, and study processes; independentlydevelop study-specificversions as directed.a. Apply knowledge of protocol and study documents and processes,during monitoringactivities,including on-site visits and in-house assessments, in response to siteactivities and inquiries.b. Regularly review and update study and site status information intorequired systemsto maintainaccurate, current reports.c. Independently prepare monitoring reports for multiple sites andprojects with no morethan 3%spelling and grammatical errors. Prepare and submit accurate and timelyconfirmation letters,monitoring reports, follow-up letters and expense reports, usingstandard templates and forms, inaccordance with SOPs and project requirements. Assist trial supervisorwith review of monitoringvisit documentation for other team members.d. Maintain essential trial and site communication records, electronicand hard copy,removingnon-essential communication to meet trial and organizational andgovernment standards asdirected.e. Develop and implement action plans for resolution ofroutine andcomplex site andstudy issues.Follow up on outstanding issues including ongoing documentation.3. Manage and reviewrouting and moderately complex site data including case report form(CRF)completion and submission, data query resolution, and overall dataintegrity according toestablished practices, with minimal to no guidance. Recommendimprovements for data collectionanddata processing and implement efficiencies as directed.a. Review specified patient data and source documents. Appropriatelyreport safetyconcerns,protocol deviations or unexpected data trends.b. Review data status reports and follow-up with sites regardingmissing and/or latedata. Observefor trends and coach sites to improve performance.c. Provide training for site personnel on appropriate sourcedocumentation, CRFcompletion, dataprocedures and timelines, and query resolution. Review data queries,assist sites with queryresolution and follow up on outstanding queries.4. Build and maintain effective working relationships with sitepersonnel, internal andexternalstudy contacts. Promote confidence in the Clinical Operationsfunctional group and the DCRI.a. Maintain appropriate professional relationships utilizing anassertive, business-likemannerwhich fosters study compliance. Develop effective working relationshipswith difficult sites.b. Provide timely notification to appropriate study contacts of sitestatus and trial relatedneeds.c. Provide clear direction to site and trial personnel on all aspectsof the clinical trialwhilefollowing project guidelines and professionally representing the DCRIand the DCRI#s clients.d. Contribute to positive team dynamics through effective listening andverbalcommunicationincluding active participation in team meetings, interaction with teammembers, sharing information,and proactive problem identification and resolution.e. Act as the point person for trial-specific activities, working withtrial team members asdirected by the trial supervisor.5. Provide routine updates and moderately complex reports to trialsupervisor(s) andother assignedcontacts to ensure timely communication regarding status of sites,study issues and resolutions,andtrial activities with minimal to no guidance.a. Communicate with teammates to consolidate accurate and completeassessments ofsites#activities. Routinely report updates to trial supervisor withoutprompting.b. Routinely communicate with internal partners as needed for trialactivities.c. Independently assess findings and recommend resolution of complexissues, utilizingtrialsupervisor as a resource to verify proposed plans.6. Serve as a resource to other team members for day-to-day trialactivities. Participateas atrainer and mentor for subordinates, peers, and site personnel.a. Assist with training lessexperienced Clin.Ops. personnel for routine on-site monitoring visitsand in-house monitoringactivities. Document training activities with minimal to no guidance.b. Develop site training materials, including site initiationactivities, agendas, slides, andstudy tools.c. Provide scientific and technical training to team members based onareas ofindividual expertise.
1449 CLINICAL RESEARCH ASSOCIATE II
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, genetic information, gender, genderidentity, national origin, race, religion, sexual orientation, orveteran 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.
Work requires graduation from. an accredited degree program providingclinical training as a Registered Nurse (RN), Physician's Assistant(PA) or Pharmacist plus two years of healthcare experience; or one ofthe following equivalents:1. Completion of an allied health degree (e.g., Respiratory Therapy,Radiologic Technology, Licensed Practical Nurse) or Associates degree inClinical Trials Research related curriculum plus a minimum offour yearshealthcare experience; or2.Completion of a master's degree in Public Health,., HealthAdministration or a related area with. one year directly relatedclinical trials research experience; or3. Completion of a bachelor's degree plus a Minimum of two yearsdirectly related experience in clinical trials research; or4. Completion of a bachelor's degree plus a minimum of three yearsclosely related research experience.**State of North Carolina license may be required.**
None :required beyond that described above.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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.