Clinical Research Associate

vor 17 Stunden

Sydney, Österreich Merck Gruppe - Msd Sharp & Dohme Vollzeit

Job Description
Clinical Research Associate (CRA) Permanent, full-time role with competitive renumeration and benefitsRequired for individual to be based in Sydney, Australia, Macquarie ParkWork with a high performing, agile and passionate teamOpportunity to work in an area your passionate about, whilst being fully supported and encouragedThe role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems. What You Will Do Responsibilities include, however not limited to: Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.Gains an in-depth understanding of the study protocol and related procedures.Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.Participates & provides inputs on site selection and validation activities.Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased.
Subjects' right, safety and well-being are protected.Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.Supports and/or leads audit/inspection activities as needed.Performs co-monitoring visits where appropriate.Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.What You Must Have Essential: Demonstratable solid prior experience in direct site management (monitoring) in a bio/pharma/CROQualifications: B.A./B.S.
with strong emphasis in science and/or biologyFluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectivelyGood understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelinesGood understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelinesHands on knowledge of Good Documentation PracticesProven Skills in Site Management including management of site performance and patient recruitmentDemonstrated high level of monitoring skill with independent professional judgmentGood IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devicesAbility to understand and analyse data/metrics and act appropriatelyCapable of managing complex issues, works in a solution-oriented mannerPerforms root cause analysis and implements preventative and corrective actionAbility to travel domestically and internationally approximately 65%-75% of working time.
Expected travelling 2-3 days/week.Current driver's licenseWhat You Can Expect Be critical in integrating your skills for a Global leading organisation.Joining a collaborative team of likeminded individualsBe developed and supported in your roleWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status:
RegularRelocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements:
Not ApplicableShift: Valid Driving License: Hazardous Material(s): Job Posting End Date:
01/6/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date.
Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R326447
#J-18808-Ljbffr

  • Senior/Clinical Research Associate

    vor 2 Monaten

    Sydney, Österreich Southern Star Research Vollzeit

    Southern Star Research is a leading Australian, full service CRO based in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region.We recognise that attracting and retaining excellent staff is the key to developing...

  • Clinical Research Associate

    vor 1 Tag

    Sydney, Österreich I-Pharm Consulting Vollzeit

    Clinical/Medical Research (Healthcare & Medical)Job Title: Clinical Research Associate / Senior Clinical Research AssociateLocation: SydneyJoin a boutique-sized, dynamic CRO known for its personalised approach and commitment to excellence in clinical research.On offer is a collaborative environment where your contributions will make a significant...

  • Senior Oncology Research Nurse

    vor 2 Monaten

    Sydney, Österreich Scientia Clinical Research (Scr) Vollzeit

    Location: Sydney, CBD, Inner West & Eastern SuburbsIndustry: Healthcare & Medical, Clinical/Medical ResearchNursing – High Acuity (Healthcare & Medical)Position: Full timeJoin the Scientia Clinical Research (SCR) team State-of-the-art early phase clinical research facility located in The Bright Alliance Building, Randwick, NSW.Multi-functional team of...

  • Senior Clinical Research Associate

    vor 2 Monaten

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Clinical/Medical Research (Healthcare & Medical) Job Title: Clinical Research Associate / Senior Clinical Research AssociateLocation: Sydney or Queensland Join a boutique-sized, dynamic CRO known for its personalised approach and commitment to excellence in clinical research.On offer is a collaborative environment where your contributions will make a...

  • Clinical Research Associate

    vor 4 Wochen

    Sydney, Österreich Iqvia Vollzeit

    Clinical Research Associate 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.Currently seeking Senior Clinical Research Associate in Melbourne or Perth.You must...

  • Senior Clinical Research Associate

    vor 2 Monaten

    Sydney, Österreich I-Pharm Consulting Vollzeit

    Clinical/Medical Research (Healthcare & Medical) Job Title: Clinical Research Associate / Senior Clinical Research AssociateLocation: Sydney or QueenslandJoin a boutique-sized, dynamic CRO known for its personalised approach and commitment to excellence in clinical research. On offer is a collaborative environment where your contributions will make a...

  • Senior Clinical Research Associate

    vor 2 Wochen

    Sydney, Österreich Nes Fircroft Vollzeit

    Senior Clinical Research AssociateAre you passionate about advancing medical research and improving patient outcomes? Do you thrive in a dynamic, collaborative environment where your expertise makes a significant impact? We are seeking a talented Senior Clinical Research Associate in Australia. Role Overview:As a Senior Clinical Research Associate, you will...

  • Clinical Research Associate

    vor 17 Stunden

    Sydney, Österreich This Is An It Support Group Vollzeit

    Are you passionate about making a positive and impactful difference to the lives of others through Clinical Research?Join Alexion as a Clinical Research Associate.About Alexion, Astra Zeneca Rare Disease At Alexion, we're dedicated to delivering life-changing medicines for those with rare and devastating diseases.Our patient first approach informs all our...

  • Clinical Research Associate

    vor 1 Monat

    Sydney, Österreich Merck Sharp & Dohme Corp. Vollzeit

    Job DescriptionClinical Research Associate (CRA)Permanent, full-time role with competitive remuneration and benefitsRequired for individual to be based in Sydney, Australia, Macquarie ParkWork with a high performing, agile and passionate teamOpportunity to work in an area you are passionate about, whilst being fully supported and encouragedThe role is...

  • Clinical Research Associate

    vor 2 Monaten

    Sydney, Österreich Merck Sharp & Dohme Corp. Vollzeit

    Job DescriptionClinical Research Associate (CRA) Permanent, full-time role with competitive remuneration and benefitsRequired for individual to be based in Sydney, Australia, Macquarie ParkWork with a high performing, agile and passionate teamOpportunity to work in an area you are passionate about, whilst being fully supported and encouragedThe role is...

  • Clinical Research Associate

    vor 2 Monaten

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Job Description Clinical Research Associate (CRA) Permanent, full-time role with competitive remuneration and benefits Required for individual to be based in Sydney, Australia, Macquarie Park Work with a high performing, agile and passionate team Opportunity to work in an area you are passionate about , whilst being fully supported and encouraged The role is...

  • (Senior) Clinical Research Associate

    vor 2 Wochen

    Sydney, Österreich Icon Vollzeit

    Clinical Research Associate II/ Senior Clinical Research Associate Location: Sydney or Melbourne As an experienced Clinical Research Associate, you will play a key role in improving the lives of patients by accelerating the development of our customers' drugs and devices through innovative solutions.You will be partnering with one of our global...

  • In-House Clinical Research Associate

    vor 1 Monat

    Sydney, Österreich Alira Health Group Vollzeit

    In-House Clinical Research AssociateApply Locations: Boston-RemoteTime Type: Full timePosted on: Posted 30 Days AgoJob Requisition ID: JR000039Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open...

  • In-House Clinical Research Associate

    vor 1 Monat

    Sydney, Österreich Alira Health Group Vollzeit

    In-House Clinical Research Associate Apply Locations: Boston-Remote Time Type: Full time Posted on: Posted 30 Days Ago Job Requisition ID: JR000039 Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration.Where all contributions and new ideas are explored with an open...

  • Clinical Research Associate

    Vor 3 Tagen

    Sydney, Österreich Innovationaus.Com Pty Ltd Vollzeit

    Clinical/Medical Research (Healthcare & Medical) Full timeAdd expected salary to your profile for insightsLocation: Sydney/ Australia (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...

  • Senior Clinical Research Associate

    vor 2 Monaten

    Sydney, Österreich Engineeringuk Vollzeit

    (Senior) Clinical Research Associate Location: Sydney (hybrid) As a (Senior) Clinical Research Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous...

  • (Senior) Clinical Research Associate

    vor 4 Wochen

    Sydney, Österreich Iqvia Vollzeit

    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.Currently seeking a (Senior) Clinical Research Associate in Sydney or Melbourne.You must have at least 3 years...

  • Clinical Research Associate

    vor 2 Monaten

    Sydney, Österreich Icon Vollzeit

    Role: CRA IILocation: Sydney/ Australia (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 pharmaceutical...

  • Senior Clinical Research Associate

    vor 1 Monat

    Sydney, Österreich Genesiscare Vollzeit

    Senior Clinical Research Associate - CROCare To join the Team?GenesisCare CRO is a full-service oncology CRO specialising in radiopharmaceutical development. We help pharma and biotech companies accelerate drug development, facilitate collaborative research efforts, bridge the translational gap, enhance diagnostic capabilities, and engage a global network of...

  • Research Associate

    vor 4 Wochen

    Sydney, Österreich The University of Notre Dame Australia Employees, Location ... Vollzeit

    Description Research Associate, School of Medicine Sydney campus Full-time opportunity, Fixed term contract (3 years) Rewarding opportunity Friendly and collaborative environment $81,363 to $108,484 pa (Level A) + 14.25% superannuation About the university The University of Notre Dame Australia is a private Catholic University with over 1,000 permanent staff...