Clinical Research Associate

2 weeks ago

Mississauga, Canada AstraZeneca Full time

**Clinical Research Associate - Biopharm**

**Greater Toronto Area (Field based)**

**12 Month Contract**

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**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 enhance the recruitment period to deliver clinical studies to plan
- Lead strategies for patient recruitment to meet recruitment targets
- Share knowledge and mentor 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 improve 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 efficient 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

**As Local Study Team Representative, you will**:

- Build and maintain the study summary sheet with input from Local Study Team colleagues
- 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 CRA experience preferred but will consider strong study coordinator experience
- Previous experience in the following therapeutic areas an asset: Respiratory, CVRM
- A valid driver's license
- Ability to travel and work flexible hours (overnight travel is 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

**Great People want to work with us Find out why**:

- GTAA Top Employer Award for 9 years
- Learn about our culture
- Learn more about working with us in Canada
- View our YouTube channel

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