Unique Non-Travelling regional CRA positions with our global CRO aligned with a large reputable sponsor. What will you be doing?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 ASVMetrics/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 SciencesMust be located in CanadaWill work on US trials 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.
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.
