Sub-Investigator

Job SummaryThe Sub-Investigator, under the supervision of the Principal Investigator, is responsible for both clinical and educational aspects of clinical trial studies while focused on interpreting clinical protocols and conducting study visits with subjects.Key ResponsibilitiesClinical ResponsibilitiesInterpret clinical protocolsCreate telephone screening tools for the call center's use in pre-screening patientsCreate study summaries, providing a basic overview of the research study as a reference for staff.Advise on Inclusion/Exclusion set upDraft correspondence to subjects and follow up letters to primary care physiciansBe familiar with all assigned studiesBe a resource for all staff clinical questionsReview marketing materials and give clinical inputAdditional duties and projects as assignedConduct study visits with subjectsAdhere to good clinical practices and FDA human subject protection guidelinesAdminister Informed ConsentReview and record medical historiesReview and record physical assessmentsReview inclusion/exclusion criteria to determine patient eligibilityReview and record medications, indications for use, dates of useAssess patient compliance with study drug and follow-up visitsAssess patient's response to therapyReview and sign off on lab results and tests in consultation with Principal Investigator if neededReview ECG's and provide a provisional interpretation Assess and document adverse events per company SOPs with final sign off by the Principal InvestigatorsConduct other visit procedures as assigned by supervisor and delegated by Principal InvestigatorMay share on-call responsibilities as needed to support subjects in trials Educational ResponsibilitiesTrain applicable staff on informed consentTrain recruitment/marketing team on telephone screen tools/protocolsAssist in recruitment team training Assist staff in understanding clinical requirements of the protocolAttend Investigator's Meetings for new studies, as neededPerform "Free Screen" assessments, provide interpretation and education regarding results. Provide in-services on scientific rationales of studies for clinical staff, as needed. Develop, attain, and provide patient education regarding the clinical trial process as well as diseases and treatments Assist in writing for RCR website and newsletter as neededAssist with workplace wellness initiativesQualificationsExcellent verbal and written communication skills.Excellent interpersonal and customer service skills.Education and ExperienceNP with NYS certification as Family or Adult NP or PAAt least two years' clinical experience preferred

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