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Clinical Research Associate - Oncology - Canada (remote)

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  • Job
    Full-time
    Junior & Mid Level
  • Research & Development
    Healthcare
  • Canada, +1
    Remote

Requirements

  • Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
  • Must be located in Canada
  • Will work on US remote monitoring only
  • Have a minimum of 2 -3 years’ experience in monitoring pharmaceutical industry clinical trials
  • Have a minimum of 1-3 years' experience monitoring Oncology trials
  • Knowledge of several therapeutic areas
  • Analytical/risk-based monitoring experience is an asset
  • Ability to actively drive patient recruitment strategies at assigned sites
  • Ability to partner closely with investigator and site staff to meet all of our study timelines
  • Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
  • Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
  • Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
  • To qualify, applicants must be legally authorized to work in Canada, and should not require, now or in the future, sponsorship for employment visa status.

Responsibilities

  • Works on multiple trials within Oncology
  • Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes
  • Mentors/coaches junior flex team
  • Acts as Lead SM-training other SMs on study
  • Develops site start up documents for studies including SIV agenda
  • Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines)
  • Represents LTMs or SMs on SMTs/meetings
  • Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
  • Supports country budget development and/or contract negotiation in liaison with CCS colleagues
  • Assists with ASV
  • Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.

FAQs

Is this position a remote job?

Yes, this position is remote, but it requires candidates to be located in Canada.

What qualifications are needed for this role?

Candidates should have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences, and at least 2-3 years of experience in monitoring pharmaceutical industry clinical trials, with 1-3 years specifically in Oncology trials.

What skills are necessary for success in this role?

Strong communication and influencing skills, the ability to drive patient recruitment strategies, expertise in Good Clinical Practice and ICH guidelines, as well as experience in using various clinical trial management systems are essential.

Do I need to be authorized to work in Canada?

Yes, applicants must be legally authorized to work in Canada and should not require sponsorship for employment visa status now or in the future.

Are there opportunities for mentoring in this role?

Yes, this position involves mentoring and coaching junior team members and taking on leadership roles during certain initiatives.

What types of trials will I be working on?

You will be working on multiple trials within the Oncology therapeutic area.

Is there any support for continuing education or professional development?

While the job description does not specifically mention continuing education, ICON values the quality of its people and offers a diverse culture that nurtures talent, which may include opportunities for professional growth.

What benefits are offered for this position?

Benefits include various annual leave entitlements, health insurance offerings, competitive retirement planning, access to a global employee assistance programme, life assurance, and flexible optional benefits like childcare vouchers and discounted gym memberships.

What is the company’s stance on diversity and inclusion?

ICON is committed to creating a diverse and inclusive environment and provides equal consideration for employment without discrimination. They focus on nurturing a diverse workforce and strive to be an inclusive organization.

Will I be involved in study document reviews?

Yes, you will provide the Site Manager's "voice" during the review of study documents, such as Monitoring Guidelines.

The business community for LGBTQ+ professionals, graduates, inclusive employers and advocates for workplace equality.

Technology
Industry
11-50
Employees
2014
Founded Year

Mission & Purpose

myGwork is the largest global platform for the LGBTQ+ business community. Our mission is to make the workplace more inclusive for all by providing individual users and partner organizations access to a wide eco-system of services, including job opportunities, training, mentoring, employer branding, and free community events. Joining the platform is free for individual members, which supports myGwork’s goal of ensuring that the platform's benefits are as accessible and as far-reaching as possible. Corporate members get a tailored service, with carefully curated product packages to help them achieve all their DE&I goals. myGwork organizes two annual events, WorkFair – the largest virtual global career fair for the LGBTQ+ professionals, graduates and students, and WorkPride – a week-long global conference for the LGBTQ+ business community and allies during Pride Month. The company also recently launched the myGwork Academy, delivering practical and relevant LGBTQ+ training education to help create inclusive workplaces for all.

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