Green Lane Coordinating Centre LtdClinical Research AssociateAuckland, Auckland City$27 - $29 HourlyContractorGain entry into pharmaceutical industryWorld class training for this key industry roleGlobal clinical trial experience gainedACCOUNTABILITY 1To coordinate and manage clinical trial projects conducted at GLCC:Coordinate/manage project(s), planning and logistics, within project timelines.Conduct Remote monitoring visits/Site Initiation Visits/Close-Out Visits in accordance with GLCC SOPs/Monitoring Plan and sponsor SOPs.Assist GLCC DCR and PM as required.Prepare and distribute trial specific regulatory documents to study sites, review returned documents and assess quality before filing in the Trial Master File.Independently conduct the accomplishments of one or more protocols with multiple sites to ensure compliance with GCPs, study protocols, SOPs, FDA and ICH regulations including investigator selection, preparing/ reviewing regulatory documents and preparing reports while meeting timelines/milestones.Maintain study files both at the site level and study level in the Trial Master File.Prepare or assist with Ethics Committee (EC) and, as required, national regulatory submissions (per GLCC and/or trial specific SOPs) for approval to conduct trials at GLCC selected sites. Prepare and submit appropriate reports to regulatory bodies as required.Develop trial specific manuals and tools as required (In-service Manual, Pharmacy Manuals, Regulatory Folders and other trial specific forms including administrative procedures for receipt, storage, distribution and destruction of clinical supplies, safety reporting and clinical hotline services, tracking spreadsheets/databases, training tools, etc) in accordance with GLCC SOPs and in conjunction with Study Sponsors.Liaise with study Principal Investigator and other key study personnel including sponsors for site and project management issues.Liaise with study sponsor, Study Management /Data Management personnel and DCR or designee for event management of study specific meetings.Coordinate individual contracts between sites and the trial sponsor, which are applicable to the regulations for each region or country.Review and adapt study materials, including worksheets, on an ongoing basis.Ensure efficient running of trials managed by GLCC with respect to satisfactory enrolment figures, timely completion of Case Report Forms (CRFs), queries and processing of study related data correspondence.Complete and submit monitoring reports as per the timelines for the study outlined in the monitoring plan or GLCC/Sponsor SOP. Including all required letters pre and post visit.Follow up of all items outstanding from previous visit before the next monitoring visit is conducted.Ensure accurate and complete site records are maintained and regularly update DCR or designee on trial(s) status.Organise and participate in teleconferences as required.ACCOUNTABILITY 2To maintain effective telephone/fax/e-mail communications with study sites, Coordinating Centres/Sponsoring Companies, Ethics Committees/Regulatory Agencies/others:Ensure all communications are conducted in a professional and timely manner.Maintain accurate files of study communications/correspondence.Ensure accurate and complete site records are maintained, by trial (regulatory documents, correspondence, monitoring reports, data forms, etc).Ensure accurate and complete GLCC records are maintained by trial as per the GLCC Trial Master File or as per agreed operating procedures provided by sponsors.Ensure trial documentation is transferred to and archived as per agreed applicable operating procedures.ACCOUNTABILITY 3To promote research and GLCC:Ensure work priorities are established and time-managedPlan, conduct and participate in training (formal & informal) and further personal education as appropriate.Maintain a high level of morale, enthusiasm and a good-co-operative environment enabling to facilitate good team work.Maintain professional internal and external working relationships.Understand the needs of othersUse best endeavours to promote and protect the interests of GLCC.Reference Number: GLCC-2401Profession / Role: Science & Technology / OtherEmployer: Green Lane Coordinating Centre LtdDate Posted: 25th Nov, 2024Date Expires: 24th Dec, 2024
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