Clinical Research ManagerThe Clinical Research Manager (CRM) is responsible for supporting the daily activities of Research team members to ensure all projects are completed on time and in compliance with all standards.
In addition, the CRM manages the team comprised of various roles and serves as an important knowledge resource in their department.
The CRM will work directly under the Director of Research and the principal investigator on various studies.Supervises staff classified as:Study Coordinator I – IIIRecruiter / ScreenerLab TechnicianData (Entry) CoordinatorsAdheres to compliance activities, including but not limited to:Standard Operating ProceduresAccepted Clinical PracticesCurrent regulations and guidelines associated with Local, State & Federal law, Food & Drug Administration (FDA), Code of Federal Regulations (CFR), The International Conference on Harmonization (ICH), Institutional Review Board (IRB)Manages Administrative functions:Perform a variety of administrative duties requiring a high level of knowledge of study-specific protocolsParticipate in staff hiring and schedule trainingTrain other Clinical Research Study Team membersOversee day-to-day study-related responsibilities, which may vary with each clinical trialSupervise research staff and ensure that they are reviewed regularly, remain relevant, and adhere to policy and proceduresAssist Director of Research in developing strategies for recruitment as appropriate to meet or exceed target enrollmentsDistribute and coordinate work assignmentsReview study protocol with the Research coordinators, data coordinators, and investigators and ensure everyone is aware of their roles and responsibilitiesEvaluate staff performanceInteracts with Sponsors and related representatives to:Initiates the conversation with the Clinical Research Associate who works for the Contract Research Organization employed by the sponsorParticipate in the Site Qualification Visit, Interim Monitoring Visit, Site Initiation Visit, and Close Out VisitServe as the main point of contact after the Site Initiation Visit (SIV) for all monitoring activitiesInitiate scheduling of participant clinic visits and ongoing study visitsAttend participant visits, as needed to ensure clinical procedures, lab tests, and other protocol-specific activities are completed as outlined in the protocolsInstruct subjects in protocol procedures, medication compliance, concomitant medications, accurate diary maintenance, self-rating scales, and schedule of eventsProvide close oversight and review of data collection, data entry as well as protection of data integrity for all studies assigned to the research teamProvide quality control review of subject/patient charts prior to randomization or screen fail to ensure accuracy of status determinationMonitor enrollment and provide enrollment updates for the clinical team and sponsorsServe as point of contact to clinical research staff, patient navigators, and sponsors for study-specific informationSupervise timely and accurate transcription of information on source documents, paper Case Report Forms (CRFs), and electronic CRFsRespond to data queries and other requests from data coordinators and study monitors in a timely mannerProvide backup for other Clinical Research Coordinators and Data coordinators, as neededInterface with Clinical Research Associate and company personnel assigned to the studyPrepare for monitoring visits to ensure the necessary information is available to the monitor, andAccompany the monitor during monitoring visitsOrganizes Evaluation Criteria:Specific metrics relating to meeting enrollment goalsProficiency in managing compliance with study guidelinesQuality Control Metrics, including measures such as a low rate of return for clarifying questions from the Contract Research Organization (CRO)Other functions and ResponsibilitiesThis job description does not cover or contain a comprehensive listing of activities, duties, or responsibilities required for this job.
In addition, duties, responsibilities, and activities may change at any time with or without notice.CompetenciesPatient & Customer FocusEthical ConductFlexibilityInitiativePersonal Effectiveness/CredibilityStress Management/ComposureHigh attention to detail and strong organizational skillsExcellent written and verbal communication skillsAbility to work well independentlyMaintain confidentialityExperience with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)Possess strong skills for multitasking, meeting competing deadlines, prioritizing, and supporting PIs for multiple projectsQualificationsRequiredCollege Degree in the field of sciences3 years or more Clinical Research experience3 years or more Supervisor experiencePreferredNursing or Medical DegreeHIPAA complianceBilingual/SpanishClinical Research Certification