Manager Research EMR Operations

Mission

People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

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

As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.