Clinical Research Manager

JOB SUMMARY The 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 DUTIES AND ESSENTIAL JOB FUNCTIONS Supervises staff classified as Study Coordinator I IIIRecruiter ScreenerLab TechnicianData Entry Coordinators Adheres to compliance activities including but not limited to Standard Operating ProceduresAccepted Clinical Practices Current regulations and guidelines associated withLocal State & Federal lawFood & Drug Administration FDA Code of Federal Regulations CFR The International Conference on Harmonization ICHInstitutional 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 training Train other Clinical Research Study Team members Oversee 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 assignments Review study protocol with the Research coordinators data coordinators and investigators and ensure everyone is aware of their roles and responsibilitiesEvaluate staff performance Interacts 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 events Provide 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 subjectpatient 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 information Supervise 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 manner Provide backup for other Clinical Research Coordinators and Data coordinators as needed Interface 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 visits Organizes Evaluation Criteria Specific metrics relating to meeting enrollment goalsProficiency in managing compliance with study guidelines Quality Control Metrics including measures such as a low rate of return for clarifying questions from the Contract Research Organization CRO Other functions and Responsibilities Other functions and Responsibilities This 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 COMPETENCIES Patient & Customer FocusEthical Conduct Flexibility InitiativePersonal EffectivenessCredibilityStress ManagementComposureStress ManagementComposure High attention to detail and strong organizational skillsExcellent written and verbal communication skillsAbility to work well independentlyMaintain confidentialityExperience with Microsoft Office Suite Outlook Word Excel PowerPointPossess strong skills for multitasking meeting competing deadlines prioritizing and supporting PIs for multiple projects QUALIFICATIONS Required College Degree in the field of sciences3 years or more Clinical Research experience3 years or more Supervisor experience Preferred Nursing or Medical DegreeHIPAA complianceBilingualSpanishClinical Research Certification #J-18808-Ljbffr