Clinical Research Associate
1 week ago
Clinical Research Associate or Senior Clinical Research Associate
- Permanent fulltime role with competitive remuneration and benefits
- Required for individual to be based in
Sydney, Melbourne, or Brisbane - Work with a high performing, agile and passionate team
- Both CRA and SCRA encouraged to apply
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.
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 indepth 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 onsite monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased. Subjects' right, safety and wellbeing are protected.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive and accurate visit & nonvisit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study startup, study maintenance and study closeout.
- 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 comonitoring 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
-
Experience in direct site management (monitoring) experience in a bio/pharma/CRO
-
Qualifications: B.A./B.S. with strong emphasis in science and/or biology
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Ability to understand and analyse data/metrics and act appropriately.
- Capable of managing complex issues, works in a solutionoriented manner.
- Performs root cause analysis and implements preventative and corrective action.
What You Can Expect
- Be critical in integrating your skills for a Global leading organisation.
- Joining a
collaborative team of
likeminded individuals - Be
developed and supported in your role
Who we are
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.
-
Clinical Research Associate
1 week ago
Macquarie Park, Australia MSD Full time**Clinical Research Associate (CRA)** - ** Permanent, full-time** role with competitive renumeration 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 your passionate about**, whilst being fully supported and...
-
Clinical Research Associate
2 weeks ago
Macquarie Park, Australia AstraZeneca Full timeAre you passionate about making a positive and impactful difference to the lives of others through Clinical Research? Join AstraZeneca as a Clinical Research Associate working on the BioPharmaceutical pipeline. **About AstraZeneca** Our belief powers us to push the boundaries. As we improve success rates, we keep moving forward. Celebrating both successes...
-
Clinical Research Associate
6 days ago
Macquarie Park, Australia AstraZeneca Full timeAre you passionate about making a positive and impactful difference to the lives of others through Clinical Research? Join AstraZeneca as a Senior Clinical Research Associate working on the Biopharmaceutical pipeline. **About AstraZeneca** We are a biopharmaceutical company driven by a strong sense of purpose, bringing a patient-centric approach to...
-
Clinical Research Associate
1 week ago
Macquarie Park, Australia AstraZeneca Full timeAre you passionate about making a positive and impactful difference to the lives of others through Clinical Research? Join AstraZeneca as a Senior Clinical Research Associate working on the Biopharmaceutical pipeline.About AstraZenecaWe are a biopharmaceutical company driven by a strong sense of purpose, bringing a patient-centric approach to everything we...
-
Clinical Research Associate
3 days ago
Macquarie Park, Australia MSD Australia Full timeJob DescriptionClinical Research Associate (CRA)Permanent, full-time role with competitive renumeration and benefitsRequired for individual to be based in Sydney, Australia, Macquarie Park Work with a high performing, agile and passionate teamOpportunity to work in an area your passionate about, whilst being fully supported and encouragedThe role is...
-
Clinical Trials Start-up/operations Associate
2 months ago
Macquarie Park, Australia MSD Full time**Clinical Trials Start-Up/Operations Associate** - ** Looking for a different challenge as an **Clinical Trials Start-Up/Operations Associate **whereby you can still utilise your skills? - ** Permanent Full-time **position with **competitive renumeration **and** benefits** - Location**:Macquarie Park, Sydney** - Modern office environment, a **dedicated and...
-
Clinical Quality Associate Director
1 week ago
Macquarie Park, Australia AstraZeneca Full timeDo you have experience in clinical operations and a passion for excellence? An exciting new opportunity to use your expertise to help us identify quality and process improvements within our newly formed Oncology Clinical TeamAbout AstraZenecaAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery,...
-
Clinical Research Manager
1 week ago
Macquarie Park, Australia MSD Full timeOpportunity to join a leading global biopharma company Exciting chance to work with passionate and collaborative teams Be at the centre of innovation and excellence in execution.Our Clinical Research and Pharmacovigilance team pushes global healthcare boundaries through research and innovation. Through clinical trials and surveillance, we ensure the safety...
-
Clinical Research Manager
2 weeks ago
Macquarie Park, Australia MSD Full timeWith support of other CRMs and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. The aCRM could be responsible...
-
Macquarie Park, Australia MSD Full timeClinical Trials Start-Up/Operations Associate- Looking for a different challenge as an Clinical Trials Start-Up/Operations Associate **whereby you can still utilise your skills?- Permanent Full-time position with competitive renumeration and benefits Location:Macquarie Park, Sydney Modern office environment, a dedicated and welcoming team- Upskill and...
-
Clinical Research Associate
6 days ago
Macquarie Park, Australia Healthcare Professionals Group Full time**Overview** - Work directly for a sponsor - Carry out monitoring activities across a wide range of trials - Remote / on-site hybrid role **Benefits** - Work for a top tier multinational pharmaceutical company - Close knit and supportive team with great developmental opportunities - Work on some exciting new product portfolios - Attractive salary...
-
Clinical Research Manager
1 week ago
Macquarie Park, Australia MSD Full timeWith support of other CRMs and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.The aCRM could be responsible...
-
Clinical Research Associate
2 weeks ago
Macquarie Park, Australia Healthcare Professionals Group Full timeOverview Work directly for a sponsor Carry out monitoring activities across a wide range of trials Remote / onsite hybrid roleBenefits Work for a top tier multinational pharmaceutical company Close knit and supportive team with great developmental opportunities Work on some exciting new product portfolios Attractive salary packageAbout the companyOur client...
-
Clinical Quality Associate Director
4 weeks ago
Macquarie Park, Australia AstraZeneca Full timeDo you have experience in clinical operations and a passion for excellence? An exciting new opportunity to use your expertise to help us identify quality and process improvements within our newly formed Oncology Clinical Team! **About AstraZeneca** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the...
-
Associate Clinical Operations Manager 1
1 week ago
Macquarie Park, Australia MSD Full timeAssociate Clinical Operations Manager I (aCOM-I) Permanent fulltime role with competitive renumeration and benefits Work with a high performing, agile and passionate teamThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality...
-
Associate Clinical Operations Manager 1
1 week ago
Macquarie Park, Australia MSD Full timeAssociate Clinical Operations Manager I (aCOM-I) Permanent fulltime role with competitive renumeration and benefits Work with a high performing, agile and passionate teamThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality...
-
Clinical Trials Start-Up/Operations Associate
1 month ago
Macquarie Park, Australia MSD Australia Full timeJob DescriptionClinical Trials Start-Up/Operations AssociateLooking for a different challenge as an Clinical Trials Start-Up/Operations Associate whereby you can still utilise your skills?Permanent Full-time position with competitive renumeration and benefitsLocation: Macquarie Park, SydneyModern office environment, a dedicated and welcoming teamUpskill and...
-
Research Associate
2 weeks ago
Port Macquarie, New South Wales, Australia Charles Sturt University Full timeDiverse and varied areas of research Unique opportunity to develop your skills Regionally based campuses with remote working opportunity The RoleFixed Term, Part time (Duration and FTE dependent on the project funding) Level A - $91,465 (plus 17% superannuation) – Prorated to FTE Albury-Wodonga, Bathurst, Dubbo, Orange, Port Macquarie, Wagga Wagga (Remote...
-
Associate Director, Perioperative Services
3 weeks ago
Macquarie Park, Australia Macquarie University Hospital Full timePRIMARY DETAIL As an experienced Senior Perioperative Nursing Manager, we want you to bring your private healthcare experience to MQ Health and Macquarie University. - Join an organisation that seamlessly links the research and clinical practice to provide outstanding patient outcomes - Full time senior perioperative nursing role across our dynamic...
-
Clinical Care
1 week ago
Macquarie Park, Australia HARTMANN Full timeAt HARTMANN, we're all in to help, care, protect and grow.We support healthcare professionals, so they can focus on what really matters: to positively impact people ́s life. We realize solutions that make a difference. And with your commitment you can grow in your job every day. At HARTMANN we believe in the difference you can make.Join Our Team at HARTMANN...