Sr. Clinical Research Associate - Vancouver

Job summary

The role involves leading site management activities, mentoring junior team members, and developing site start-up documentation. The CRA will also manage study sites remotely and face-to-face while ensuring adherence to monitoring guidelines and KPIs.

Job details

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development as a Clinical Research Associate. These is a great opportunity for CRA's who are looking to get off the road and work 100% from home. As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What will you be doing? 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. Interfaces – Primary/Other: Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials. Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.) What do you need to have? Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences Must be located in Canada Have a minimum of 2+ years’ experience in monitoring pharmaceutical industry clinical trials Knowledge of multiple therapeutic areas including Oncology 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. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

What you’ll do

The role involves leading site management activities, mentoring junior team members, and developing site start-up documentation. The CRA will also manage study sites remotely and face-to-face while ensuring adherence to monitoring guidelines and KPIs.

Requirements

Candidates must have a minimum of a Bachelor's degree in Biological Sciences or equivalent and at least 2 years of pharmaceutical clinical trial monitoring experience. Proficiency in GCP, ICH guidelines, and various clinical databases like CTMS and EDC is required.

Benefits

• Annual Leave • Health Insurance • Retirement Planning • Global Employee Assistance Programme • Life Assurance • Childcare Vouchers • Bike Purchase Schemes • Discounted Gym Memberships • Subsidised Travel Passes • Health Assessments

Listed skills

• Regulatory Compliance · Preferred
• Communication · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical Monitoring
• Site Management
• Oncology
• Risk-Based Monitoring
• Patient Recruitment
• CTMS
• EDC
• eTMF
• IWRS
• Good Clinical Practice
• ICH Guidelines
• Regulatory Compliance
• Mentoring
• Communication
• Influencing Skills
• Site Start Up

Job areas

• Healthcare
• Science & Research
• Manufacturing