Clinical Research Associate

6 days ago

Auckland, New Zealand Green Lane Coordinating Centre Ltd Full time

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
#J-18808-Ljbffr

  • Clinical Research Associate Ii/Senior Clinical Research Associate

    2 days ago

    Auckland, New Zealand Premier Research Group Full time

    Clinical Research Associate II/Senior Clinical Research AssociateApply locations: New Zealand, AustraliaTime type: Full timePosted on: Posted 8 Days AgoJob requisition id: R4401Premier Research is looking for a Clinical Research Associate II/Senior Clinical Research Associate to join our Clinical Data Sciences team.You will help biotech, medtech, and...

  • Clinical Research Associate Ii/Senior Clinical Research Associate

    2 days ago

    Auckland, New Zealand Pharmiweb Partner Job (Apac) Full time

    Premier Research is looking for a Clinical Research Associate II/Senior Clinical Research Associate to join our Clinical Data Sciences team.You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and...

  • Clinical Research Unit Manager

    4 weeks ago

    Auckland, New Zealand P3 Research Full time

    Exciting Opportunity for a Clinical Research Unit Manager – Join a Leading Clinical Trials Network!Are you passionate about shaping the future of healthcare by contributing to innovative clinical trials? Do you want to be part of a dynamic and supportive team, working with cutting-edge research that explores tomorrow's medicines today? If so, we want to...

  • Experienced Clinical Research Associate

    6 months ago

    Auckland City, New Zealand Medpace, Inc. Full time

    Job Summary: Medpace is growing quickly and we are seeking experienced Independent Contractors for the position of **Clinical Research Associates** to join our team. We are an innovative, scientifically oriented mid-sized CRO that is focused on full-service project work. Responsibilities: - Conduct qualification, initiation, monitoring, and closeout visits...

  • Clinical Research Associate

    3 months ago

    Auckland City, New Zealand ICON Full time

    **Role**: CRA II **Location**: Auckland/ New Zealand (hybrid - working from home and from the sponsor office during onboarding) As an experienced Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be working alongside a world-leading...

  • Clinical Research Associate

    1 week ago

    Auckland City, New Zealand Green Lane Coordinating Centre Ltd Full time

    **Green Lane Coordinating Centre Ltd** **Clinical Research Associate**: **Auckland, Auckland City** $27 - $29 Hourly Contractor - **Gain entry into pharmaceutical industry**: - **World class training for this key industry role**: - **Global clinical trial experience gained** **ACCOUNTABILITY 1** **To coordinate and manage clinical trial projects...

  • (Senior) Clinical Research Associate

    6 months ago

    Auckland City, New Zealand Novasyte Full time

    This is not your usual FSP model - they are family owned and have been distinctly independent for over 130 years. Their corporate values and culture are the bedrock of the company's distinctive character. Please note, this opportunity is exclusive to our New Zealand location. Your primary mission will involve becoming the pivotal connection between...

  • Clinical Research Associate Ii

    6 months ago

    Auckland City, New Zealand ABBVIE Full time

    Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality...

  • Research Associate

    4 months ago

    Auckland City, New Zealand Science New Zealand Full time

    **Research Associate** **Molecular Sensing** **Mt Albert, Auckland** **Permanent Fulltime (38 hours per week)** **Vacancy number 56221** Do you have an interest in human clinical trials and are looking to build your career in this area? Do you have exceptional communication skills, enjoy working with a wide range of people, have an eye for detail in data...

  • Inhouse Clinical Research Associate

    6 months ago

    Auckland City, New Zealand Novotech Asia Full time

    **Minimum Qualifications & Experience**: - Relevant experience/qualifications in Life Sciences or related field or administration would be preferable. Experience working in the pharmaceutical, CRO or healthcare industry is advantageous. **Responsibilities**: - Support the clinical team's inhouse activities on assigned projects - Co-ordinate and maintain...

  • Clinical Study Startup Associate

    6 months ago

    Auckland City, New Zealand Recruit Shop Full time

    **Join a Cutting-Edge Clinical Research Site Network in Auckland, New Zealand**: - **Full-Time Role with Flexible Hours | Hybrid Office & Work From Home Role**: - **Close Knit Team Working Towards a Common Goal | Growth & Development**: **About The Company**: Our client operates across 9 clinical study sites in New Zealand and they recognise the positive...

  • Clinical Research Coordinator

    6 months ago

    Auckland City, New Zealand Te Whatu Ora -Health New Zealand Te Toka Tumai Auckland Full time

    **Be part of an innovative research team recognised worldwide** - **One year fixed term role** **Te whiwhinga mahi | The Opportunity** Vascular and Interventional Research Unit (VIRU) is looking for a Clinical Research Coordinator to join our team. As a Clinical Research Coordinator: - You will work alongside Study sponsors, Study participants and...

  • Clinical Research Lead

    4 days ago

    Auckland City, New Zealand University of Auckland Full time

    **Company Description** Waipapa Taumata Rau** **| The University of Auckland** The Faculty of Medical and Health Sciences is a diverse faculty with more than 4,000 students studying across six schools, led by world-leading researchers. We are committed to improving the health of our local, national and global communities through excellence in teaching,...

  • (Senior) Clinical Research Associate

    4 months ago

    Auckland City, New Zealand IQVIA Full time

    Step into a dynamic role where you’ll drive innovation and excellence in clinical research. As a key player in our team, you’ll ensure that study sites are not just compliant but thriving, contributing to groundbreaking advancements in healthcare. **Essential Functions**: - ** Engage in Site Visits**: From selection to close-out, your visits will be...

  • Clinical Research Scientist

    4 weeks ago

    Auckland, New Zealand Fisher & Paykel Healthcare Full time

    Fisher & Paykel Healthcare – Auckland, North IslandFull timeWe are looking for a Clinical Research Scientist to join our Surgery team. Our surgery products and therapies provide a wide range of research opportunities from deeper learnings of key clinical outcomes to exploring mechanisms of actions for products under development. Join our driven, innovative...

  • Clinical Research Scientist

    4 weeks ago

    Auckland, New Zealand Fisher & Paykel Healthcare Full time

    Fisher & Paykel Healthcare – Auckland, North IslandFull timeWe are looking for a Clinical Research Scientist to join our Surgery team. Our surgery products and therapies provide a wide range of research opportunities from deeper learnings of key clinical outcomes to exploring mechanisms of actions for products under development. Join our driven, innovative...

  • Senior Clinical Research Coordinator

    4 months ago

    Auckland City, New Zealand Health New Zealand - Te Whatu Ora Full time

    **Meaningful role with the ability to make a difference in research for people with cancer**: - **Be part of a team working at the cutting edge of clinical research with engaged clinical researchers and a dynamic team**: - **Permanent full time position based in Auckland City Hospital** **Te whiwhinga mahi | The Opportunity** Te Pūriri o Te Ora -...

  • Clinical Research Physician/scientist

    6 months ago

    Auckland City, New Zealand Douglas Pharmaceuticals Full time

    **The role** We are looking for a Clinical Research Physician/Scientist to work within our Medical Affairs Team. You will provide medical/clinical research expertise, in cross functional teams, to develop medicines through design, conduct and reporting of clinical studies. You will ensure that protocols, investigator's brochures and clinical trial reports...

  • Clinical Research Coordinator

    6 months ago

    Auckland City, New Zealand Te Whatu Ora -Health New Zealand Te Toka Tumai Auckland Full time

    **Are you keen to develop your researching skills working in a fast-paced environment?**: - **Full Orientation provided and supportive team**: - **Permanent, full time position, based at Auckland City Hospital** **Te whiwhinga mahi | The Opportunity** We are looking for a proactive person who is ready for a new challenge and a chance to take a step up in...

  • Lead Clinical Research Coordinator

    6 months ago

    Auckland City, New Zealand Health New Zealand - Te Whatu Ora Te Toka Tumai Auckland Full time

    **Excellent personal and professional development opportunity in Cancer and Blood Research in a fast-growing team involved in local and international research!**: - **Meaningful role with the ability to make a difference in research for people with cancer**: - **Be part of a team working at the cutting edge of clinical research with engaged clinical...