Job Details

As the Manager of Research EMR Operations you are responsible for managing the team performing clinical interpretationofprotocolsandtransfersthisinterpretationintothedetailedscheduleof events.

• You will managetheteamofEMRAnalyststoensureproductivity,qualityandtimelinemetricsare met.

• You will developrelationshipsbetweendepartmentstoensureprotocolimpactsarecommunicatedout.

• You will reviewprotocolbuildsforaccuracy,thoroughness,compliance,andsufficiency.

• You will managetheamendmentintakeprocessinwhichtheteamactsasasinglepointofcontact.

• You will serveasscientificandclinicalexpertintheinterpretationofclinicaltrialprotocols.

• You will workdirectlywithScientificDirectorand/orPhysiciansand/orProgramManagerstovalidate proper interpretation of the protocol.

• You will preparefortheSarahCannonClinicalOperationsProtocolReviewCommitteebyevaluating and assessing presenting protocols in advance to determine complexity, identify risks associatedwith a trial and operational and implementation challenges

• You will create and update the protocol specific Clinical Operation worksheet with pertinent study informationtouseasastudyleadtoolforSarahCannonClinicalOperationsandapplicablesites

• You will attendtheSarahCannonClinicalOperationsProtocolReviewCommitteetocaptureanydetails presented by the clinical and budget teams

• You will converttheprotocolintoascheduleofeventswhichshouldbecompletedwitheachpatientvisit during the life of the study.

• You will reviewallproposedamendmentstounderstandtheimpacttotheclinicaltrial.Adjustthe schedule of events to capture any adjustments specified by trial amendments.

• You will updatetheClinicalTrialManagementSystemorEMRsystemwiththeoriginalorupdated schedule of events to ensure timely notification to impacted parties.

• You will provideinitialclinicalinterpretationforeachprotocolandguidetheClinical Educatorstoinsure consistent interpretation across the organization.

• You will escalateallappropriateinformationtobudgets,finance,orClinicalOperationsmanagementas deemed necessary.

You should have for this position:

• Must have extensive oncology knowledge base of all major cancer types including disease relatedsymptommanagement,standardtreatmentoptions,andtreatment-relatedsideeffect management

• Must have knowledge of federal and state regulations and ICH guidelines pertaining to the conductofclinicaltrialsinvolvinghumansubjectsforInvestigatorandSponsorrequirements.

• Musthaveknowledgeandunderstandingoftheprinciples,processes,andethicalconsiderations in clinical trials involving human subjects

• Musthaveageneralworkingknowledgeoftheguidelines,standardsandoperating requirements of Institutional Review Boards

• MusthaveexperienceworkinginaClinicalTrialManagementSystem

• You should have a Bachelor’s Degree, Master’s Degree is preferred

• At least three years of experience in oncology

• At least three years of experience in clinical operations

• At least three years of research experience

• RN or BSN is preferred

• Research Certification (ACRP or CCRP) preferred

• Oncology Certification (OCN) preferred