Oncology Clinical Research Associate II

4 weeks ago

Canada ICON Strategic Solutions Full time

As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

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 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
  • 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

  • Oncology Clinical Research Associate II

    4 weeks ago

    Canada ICON Strategic Solutions Full time

    As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.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 •...

  • Oncology Clinical Research Associate II

    4 weeks ago

    Canada ICON Strategic Solutions Full time

    As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. 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 •...

  • Oncology Clinical Research Associate II

    4 weeks ago

    Canada ICON Strategic Solutions Full time

    As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. 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 •...

  • Oncology Clinical Research Associate II

    3 weeks ago

    canada ICON Strategic Solutions Full time

    As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.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 •...

  • Regional Senior Clinical Research Associate

    2 weeks ago

    Canada Advanced Clinical Full time

    The Senior Clinical Research Associate (Sr. CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH E6 Good Clinical Practices, FDA guidelines, local regulations and standard operating procedures.Responsible for performing the clinical monitoring aspect of designated projects in accordance with...

  • Regional Senior Clinical Research Associate

    1 week ago

    Canada Advanced Clinical Full time

    The Senior Clinical Research Associate (Sr. CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH E6 Good Clinical Practices, FDA guidelines, local regulations and standard operating procedures.Responsible for performing the clinical monitoring aspect of designated projects in accordance with...

  • Clinical Research Associate

    3 weeks ago

    Canada ICON Strategic Solutions Full time

    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...

  • Clinical Research Associate

    1 week ago

    Canada ICON Strategic Solutions Full time

    ICON Strategic Solutions is currently hiring Clinical Research Associates for various clients (major pharmaceutical/ biotech companies) FSP dedicated teams in Canada.-Current CRA openings are at the CRA II and Sr CRA levels-Full time permanent - competitive salary plus benefits-Candidate must be located in CanadaDescriptionICON plc is a world-leading...

  • Clinical Research Associate

    7 days ago

    canada ICON Strategic Solutions Full time

    ICON Strategic Solutions is currently hiring Clinical Research Associates for various clients (major pharmaceutical/ biotech companies) FSP dedicated teams in Canada. -Current CRA openings are at the CRA II and Sr CRA levels -Full time permanent - competitive salary plus benefits -Candidate must be located in Canada Description ICON plc is a world-leading...

  • Clinical Research Manager

    5 days ago

    Canada ICON Full time

    As a Clinical Research Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country...

  • Clinical Research Manager

    1 week ago

    Canada ICON plc Full time

    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. **What you will be doing**: This role is primarily accountable for the end-to-end performance...

  • Clinical Research Associate

    3 weeks ago

    canada ICON Strategic Solutions Full time

    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...

  • Clinical Research Associate

    2 days ago

    Canada Piper Companies Full time

    Piper Companies is seeking an experienced Clinical Research Associate (CRA) to join our client's team. This opportunity is with an industry-leading Clinical Research organization supporting one of the top pharmaceutical companies in the world. The CRA will play a critical role in monitoring and managing clinical trials, ensuring compliance with regulatory...

  • Clinical Data Team Lead

    7 days ago

    Canada Everest Clinical Research. Full time

    About Everest Clinical ResearchWe are a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.Our company has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of...

  • Clinical Research Associate

    5 days ago

    Canada Heads Full time

    Heads, a global CRO, is seeking a Clinical Research Associate (CRA) based in Canada for its growing international hematology/oncology Clinical Trials program.This is a full-time job.Job overview: The CRA is responsible for ensuring that the conduct of a clinical trial at selected Investigational Sites is according to the currently approved...

  • Clinical Data Research Associate

    4 weeks ago

    Canada Heads Full time

    Heads, a global CRO, is seeking a Clinical Research Associate (CRA) based in Canada for its growing international hematology/oncology Clinical Trials program. This is a full-time job. The CRA is responsible for ensuring that the conduct of a clinical trial at selected Investigational Sites is according to the currently approved protocol/amendments, ICH GCP...

  • Radiation Oncology Specialist

    2 days ago

    Canada Provincial Health Services Authority Full time

    About the RoleAs a clinical radiation oncologist, you will have the opportunity to work in a provincial radiation therapy program committed to delivering high-quality patient care.You will be responsible for providing evidence-based standardized care and participating in research, administrative, and educational activities.This position is ideal for...

  • Clinical Data Manager//(full-time, remote)

    4 weeks ago

    Canada, CA Everest Clinical Research. Full time

    Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical...

  • Clinical Data Manager//(full-time, remote)

    4 weeks ago

    Canada Everest Clinical Research. Full time

    Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices...

  • Clinical Data Manager//(full-time, remote)

    4 weeks ago

    Canada Everest Clinical Research. Full time

    Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical...