Clinical Research Associate II (Office Based) - NCR
Novella Clinical Resourcing is seeking Clinical Research Associate II (Office Based) – Multi-Therapeutic:
Oversee and review routine and moderately complex site activities, with minimalto no guidance, through monitoring activities, including on-site visits and/orin-house assessments, including telephone contact, and other technologiesaccording to the trial-specific monitoring plan. Assess protocol, regulatory,and SOP compliance with some guidance from an experienced CRA or a clinicaltrial lead. May travel up to 80% to perform on-site monitoring visits,including site selection, initiation, periodic, and close out visits. Performor assist with unexpected site visits as directed. Schedule site visitsaccording to XXXX travel policy and trial-specific guidelines while effectivelyusing cost and time saving efficiencies. Independently perform monitoringactivities for multiple sites and possibly multiple projects, identifying andreporting deviations from regulations and SOPs. Assess protocol and regulatorycompliance, including but not limited to source document verification, informedconsent process and human subject protection, data integrity, drugaccountability and compliance, and review of investigator and regulatory files.Assess adequacy of site personnel and facilities for study conduct. Providestudy training and guidance to designated site personnel for conducting studiesin accordance with the protocol, SOPs, trial specific procedures and applicableregulations. Identify situations that may affect subject safety or dataintegrity and retrain site personnel accordingly. Identify action items anddiscuss with appropriate site personnel. Communicate routine and unusualfindings to trial supervisor. Document ongoing follow-up and resolution ofissues. Recognize ongoing action items and coach site personnel to improvetheir performance. Assist sites with preparation for planned and unannouncedaudits with some guidance. Perform trial supervisory activities as directed bytrial project leader with approval of line manager. Independently documentroutine site management and clinical monitoring activities, site communication,and trial related activities. Document complex site management and clinicalmonitoring activities, site communication, and trial related activities withminimal to no guidance. Utilize monitoring tools and trial documents, recommendrevisions to improve efficiencies of monitoring tools, trial documents, andstudy processes; independently develop study-specific versions as directed.Apply knowledge of protocol and study documents and processes, duringmonitoring activities, including on-site visits and in-house assessments, inresponse to site activities and inquiries. Regularly review and update studyand site status information into required systems to maintain accurate, currentreports. Independently prepare monitoring reports for multiple sites andprojects with no more than 3% spelling and grammatical errors. Prepare andsubmit accurate and timely confirmation letters, monitoring reports, follow-upletters and expense reports, using standard templates and forms, in accordancewith SOPs and project requirements. Assist trial supervisor with review ofmonitoring visit documentation for other team members. Maintain essential trialand site communication records, electronic and hard copy, removingnon-essential communication to meet trial and organizational and governmentstandards as directed. Develop and implement action plans for resolution ofroutine and complex site and study issues. Follow up on outstanding issuesincluding ongoing documentation. Manage and review routing and moderatelycomplex site data including case report form (CRF) completion and submission,data query resolution, and overall data integrity according to establishedpractices, with minimal to no guidance. Recommend improvements for datacollection and data processing and implement efficiencies as directed. Reviewspecified patient data and source documents. Appropriately report safetyconcerns, protocol deviations or unexpected data trends. Review data statusreports and follow-up with sites regarding missing and/or late data. Observefor trends and coach sites to improve performance. Provide training for sitepersonnel on appropriate source documentation, CRF completion, data proceduresand timelines, and query resolution. Review data queries, assist sites withquery resolution and follow up on outstanding queries. Build and maintaineffective working relationships with site personnel, internal and externalstudy contacts. Promote confidence in the Clinical Operations functional groupand the XXXX. Maintain appropriate professional relationships utilizing an assertive,business-like manner which fosters study compliance. Develop effective workingrelationships with difficult sites. Provide timely notification to appropriatestudy contacts of site status and trial related needs. Provide clear directionto site and trial personnel on all aspects of the clinical trial whilefollowing project guidelines and professionally representing the XXXX and the XXXX’sclients. Contribute to positive team dynamics through effective listening andverbal communication including active participation in team meetings,interaction with team members, sharing information and proactive problemidentification and resolution. Act as the point person for trial-specificactivities, working with trial team members as directed by the trialsupervisor. Provide routine updates and moderately complex reports to trialsupervisor(s) and other assigned contacts to ensure timely communicationregarding status of sites, study issues and resolutions, and trial activitieswith minimal to no guidance. Communicate with teammates to consolidate accurateand complete assessments of site activities. Routinely report updates to trialsupervisor without prompting. Routinely communicate with internal partners asneeded for trial activities. Independently assess findings and recommendresolution of complex issues, utilizing trial supervisor as a resource toverify proposed plans. Serve as a resource to other team members for day-to-daytrial activities. Participate as a trainer and mentor for subordinates, peers,and site personnel. Assist with training less experienced Clin Ops personnelfor routine on-site monitoring visits and in-house monitoring activities.Document training activities with minimal to no guidance. Develop site trainingmaterials, including site initiation activities, agendas, slides, and studytools. Provide scientific and technical training to team members based on areasof individual expertise.
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician’s Assistant (PA) or Pharmacist plus two years of healthcare experience; or one of the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy,Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of four years healthcare experience; or 2.Completion of a master’s degree in Public Health,., Health Administration or a related area with one year directly related clinical trials research experience; or 3. Completion of a bachelor’s degree plus a Minimum of two years directly related experience in clinical trials research; or 4. Completion of a bachelor’s degree plus a minimum of three years closely related research experience.
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