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.
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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
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