Azul Vison: Research Studies Coordinator – Pasadena

Clinical Research CoordinatorJob Description* $500.00 Signing Bonus*Clinical Research Coordinator is to support the lead coordinator, but can take more task and/ or studies on independently.BCVA techTraveling BCVA tech for research departmentManagementProvide Corrective action plan for any retraining that is neededEnsure that all clinical research and related activities are performed in accordance with Federal Regulations and sponsor’s policies and proceduresMaintain and document all training per assisted protocolAssist the PI in development of materials and tools necessary to appropriately train all staff in the conduct of the study including protocol requirements and schedule of assessments and visits.Coordinate and facilitate monitoring and auditing visitsCollaborate with PI/ lead coordinator to respond to audit finding and implement recommendations as approved by PIConduct internal source document review to ensure compliant with ALCOA*Protocol Management*Review and comprehend the ProtocolAttend Investigator meeting and Coordinator Meetings (If applicable)study feasibility assessments – Send to site director to completePrepare all regulatory submission documents for IRB as required by protocolPrepare all documents needed to initiate study and submit to sponsorPrepare and maintain study related materials as requested by PI including but not limited to informed consent documents, Case report forms, enrollment logs, drug and or device accountability logsMaintain and organize source files, regulatory binders and other materialsManage daily activities of protocol management, communication and problem solving with staff and PIAssist PI in implementing preparation of any protocol amendmentsUnpack study supplies/ prepare areas designee to research and keep neat and cleanProcess and ship labs per protocol ambient and frozenComplete all tasks delegated on the DOA logs for you.Protected Health InformationAdhere to all Federal regulations and office policy and procedures, to protect all Protected Health InformationComplete and provide training regarding the access, use and disclosure of Protected Health Information, in accordance with Federal regulations, sponsors and office proceduresCooperate with office policies and procedures and monitoring efforts regarding the access and disclosure of Protected Health Information*Informed Consent Activities*Prepare consent paperwork for subjectsEnsure that consents are signed and countersigned appropriately as per GCP, FDA and sponsor requirementsConduct informed consent process including interactions with subjects to assist with any questions or concerns, Have PI present to assist with any concerns that cannot be addressed by CoordinatorsUtilize and obtain signatures on updated consent formsResearch Study ActivitiesFamiliarize with protocol, study requirements, timelines, assessments, inclusion and exclusion criteriaAssist PI/ lead coordinators in providing knowledge to all research staff involved in the studyDocument all training and obtain signatures on appropriate training logsDevelop and implement recruitment strategiesScreen Subjects for eligibility per inclusion and exclusion criteriaCoordinate and schedule all tests, procedures and appointmentsCollect data on source as per protocolComplete CRF in a timely mannerMaintain timelinesMaintain study suppliesComplete study documentation and maintain files as per requirementsRetain all required documents in accordance with sponsor and FDA guidelinesMaintain ongoing communication with sponsor and research participants during the study courseMaintain all study related equipment and specified trainingAssist the PI in promptly reporting any unanticipated problems involving risks to participants to the central IRB, including but not limited to serious adverse eventsDocument and report Protocol deviationsIP ManagementIP accountability and IP returnIP randomization as per protocolIP Temperature Control*Study Close-Out*Submit accurate and timely close-out documents to required federal agencies and sponsorSupport the monitor with all questions, query resolution, IP return and any other activitiesSecure storage of all documents to be maintained according to office policy or required time, whichever is longerLocation: 2619 E.

Colorado Blvd, Pasadena, CA 91107Job Type: Full-time