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Clinical Research Associate, Oncology (Montréal)

Ort Quebec, Québec, Kanada Anzeigen-ID R-090687 Veröffentlichungsdatum 09/17/2020

At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.

Our purpose is bold and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate entrepreneurial thinking and act with a sense of urgency. We are courageous, taking risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver medicines.

Position Title: Clinical Research Associate, Oncology

Position Type: Full-Time, 12 Month Contract

Location: Montréal  

Career Level: D

Are you motivated by building positive collaborations with partners? Do you love leading and advising on clinical studies?  As a member of Clinical Site Management and the local study teams, you represent Clinical Site Monitoring and provide input during Planning and document review, and will ensure data is clean at file stage of clinical trials. You are the subject lead on site management processes and are responsible for positively managing clinical sites from site selection to site closure.

Your responsibilities will include:

  • Build positive relationships with site partners through site selection, patient recruitment, training on AZ protocols, SOPs, clinical guidelines, and data collection; site visits and site closures
  • Influence and facilitate site documentation collection for timely initiation of sites and to maximize the recruitment period to deliver clinical studies to plan
  • Lead strategies for patient recruitment to met recruitment targets
  • Share knowledge and coach new CRA's on technical skills and positively impact the development of the regional territory including progressing valued relationships with investigators and sharing this information within AZ to enhance customer experiences
  • Ensure accuracy of patient data by verifying source data, ensuring timely reporting of Serious Adverse Event's, handling of study-drug supplies and overall management of the Investigator Study File (ISF); completes audit reports and ensures follow-up issues are completed by deadlines
  • Actively identifies study-related issues and elevates issues as appropriate.
  • Collect Customer Insights from investigative sites with documentation in appropriate systems
  • Report site and patient level information accurately in AstraZeneca clinical trial management systems within specified timelines
  • Ensure optimal management of time and expenses in support of the business
  • Ensure compliance with AstraZeneca's Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment)
  • Identify or follow-up on potential new sites and develop inexperienced sites within territory for future studies by collaborating with Commercial representatives in the territory
  • Participate in customer planning initiatives for key customers in territory
  • Assist with planning and delivery of Regional meetings
  • You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures

As Local Study Team Representative, you will:

  • Build and maintain the study summary sheet with input from Local Study Team colleagues
  • Attend team meetings, presenting feedback from the monitoring team on study specific issues for Local Study Team consideration, and disseminating information to CRA’s via email updates and teleconferences (as needed); you may attend and present at the Investigator Meeting
  • Communicate issues and risks affecting study deliverables to Manager, Clinical Research Associate (M,CRA)/Local Study Manager (LSM) for communication to the global team
  • Collaborate with Manager - CRA, LSM to identify potential risks to Data Base Lock, review unresolved/outlier data, Source Data Verification and Data Query reports, provide status update and follow-up requirements to assigned CRA and Manager – CRA including advising on the risk management plan

Your qualifications include:

  • University degree or College diploma (professional accreditation) in Health Sciences field
  • Minimum 2 years’ experience in clinical research role
  • Previous oncology experience required
  • Ability to work independently and handle fluctuating workloads
  • Professional collaboration skills, adept at influencing others and excellent communication skills
  • Detail savvy with excellent critical thinking skills
  • Possess a valid driver's license
  • Ability to travel overnight, work from home and available to work flexible hours
  • Bilingual in both French and English required

Great People want to Work with us, find out why:

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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