Based in Durham, North Carolina, Cenduit is a privately held information technology and services company specializing in Interactive Response Technology (IRT) s
Clinical Research Associate
Location
Australia
Posted
16 days ago
Salary
0
Seniority
Entry Level
Job Description
Clinical Research Associate
Cenduit
Clinical Research Associate Location: Melbourne Australia Job Description: Are you a Clinical Research Associate looking for your next big adventure? Look no further than IQVIA, a global CRO with outstanding reputation. Our CRA teams have current openings across various locations in Australia. The role: Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines - Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. - Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. - Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. - Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. - Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. - Collaborate and liaise with study team members for project execution support as appropriate. - If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. - If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications - Bachelor's Degree in scientific discipline or health care. - Requires at least 9 months of independent on-site monitoring experience. - Equivalent combination of education, training and experience may be accepted in lieu of degree. - Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines). - Good therapeutic and protocol knowledge as provided in company training. - Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). - Organizational and problem-solving skills. - Effective time and financial management skills. - Ability to establish and maintain effective working relationships with coworkers, managers, and clients. - Candidates will be assessed according to their years of experience and be considered for various levels where applicable. What's in it for you? - Flexible hybrid work environment, with an office in the heart of Melbourne and Sydney. - Competitive salary with car and health allowances. - Career growth and opportunity across our FSO and FSP models. - Work with skilled Managers across multi-phases clinical trials If you are interested and meet the skills and experience above, please apply with your resume today. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gain in-depth understanding of the study protocol and related procedures. • Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness. • Participate & provide input on site selection and validation activities. • Perform 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 evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out. • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager. • Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Supports audit/inspection activities as needed. • Travel Requirements up to 75%. • Adhere to all aspects of Ora’s quality system. • Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
TTF India Graduate Intern, MSC
Mondelēz InternationalWe’re a house of incredible brands providing people with the right snack, for the right moment, made the right way.
Job Description Are You Ready to Make It Happen at Mondelēz International? Join our Mission to Lead the Future of Snacking. Make It Matter. As an organization we are committed to developing the next generation of Makers and Bakers. Joining us at an early career stage in our fast paced and ever changing environment will enable you to do more, learn more and grow more. You will be encouraged to step outside your comfort zone- you may even surprise yourself! We will ensure you are given the support you need to be at your best and enable you to be yourself and bring passion and personality. Here you can lean in and speak up and bring your own flavor. More about this role TTF Intern hiring. No Relocation support available Business Unit Summary Mondelez India Foods Private Limited (formerly Cadbury India Ltd.) has been in India for over 70 years, making sure our mouth-watering and well-loved local and global brands such as Cadbury chocolates, Bournvita and Tang powdered beverages, Oreo and Cadbury Bournvita biscuits, and Halls and Cadbury Choclairs Gold candies get safely into our customers hands-and mouths. Headquartered in Mumbai, the company has more than 3,300 employees proudly working across sales offices in New Delhi, Mumbai, Kolkata and Chennai and in manufacturing facilities at Maharashtra, Madhya Pradesh, Himachal Pradesh and Andhra Pradesh, at our global Research & Development Technical Centre and Global Business Hub in Maharashtra and in a vast distribution network across the country. We are also proud to be recognised by Avatar as the Best Companies for Women in India in 2019 - the fourth time we've received this award. Mondelēz International is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation or preference, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Job Type Intern (Fixed Term) Interns Early Careers
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