Clinical Trials Monitor Clinical Trials Unit - BC Cancer - Remote within Lower Mainland What you'll do
- Ensure adherence to BC Cancer Clinical Trials SOPs, tools and methods.
- Conduct study initiation visits with each clinical trial site, prior to the commencement of study enrollment to discuss overview of the study protocol, study drug management administration (if applicable), subject enrollment procedures, case report form (CRF) completion, serious adverse event (SAE) monitoring and any other issues related to the study.
- In consultation with Physician, Investigators, Quality Assurance and Process Improvement Specialist prepare and implement clinical trials monitoring plans.
- Conduct onsite and remote monitoring activities to ensure that clinical trials comply with the requirements of the protocol, relevant SOPs and regulatory requirements. Review investigator files for completeness and accuracy. Confirm and review completed CRF and de-identified source documents. Document all findings in report format with identification of issues requiring follow up to the Investigator.
- Design, develop, test and maintain the study database based on requirements of the study protocol, investigator and statistician. Ensure the security of database and authorizes access to the study database for other users.
- Ensure study data is entered into the study database on an ongoing basis and that queries are addressed to trial personnel for incomplete CRF entries or necessary clarification.
- Provide and ongoing review of patient accrual to individual clinical trials.
- Ensure data confidentiality, integrity and security by following established policies, procedures and professional standards of practice for assigned work.
- Attend and participate in meetings as required and assists in preparing agendas, meeting materials, minutes and reports related to data capture and data quality issues.
What you bring
- Bachelor's degree in a related health science
- A minimum of three (3) years of recent related experience including experience monitoring complex clinical trials and monitoring, reviewing and verifying the work performed by others or an equivalent combination of education training and experience.
What you have
What's in it for you
- Working experience of administering clinical trials practices and protocols, demonstrated ability to critically review the work performed by others,
- Organize and prioritize workload,
- Function as a team member, motivator and facilitator,
- Provide effective consultation
- Operate related equipment
- Work with all related software
Every PHSA employee enables the best possible patient care for our patients and their families. Whether you are providing direct care, conducting research, or making it possible for others to do their work, you impact the lives of British Columbians today and in the future. That's why we're focused on your care too - offering health, wellness, development programs to support you - at work and at home.
Regular Full Time Location: Working Remotely within Lower Mainland Applications will be accepted until position is filled. Monday - Friday 0800-1600, 1830-1630, 0900-1700 Requisition Number: 107355 What we do
- Join one of BC's largest employers with province-wide programs, services and operations - offering vast opportunities for growth and development.
- Access to more than 2,000 in-house training programs.
- Enjoy a comprehensive benefits package, including municipal pension plan.
- 12 annual statutory holidays with generous vacation entitlement and accruement.
- Perks include onsite fitness classes and discounts to 350 BC-wide recreational programs, travel, technology, car and bike sharing, and more.
BC Cancer bccancer.bc.ca provides comprehensive cancer control for the people of British Columbia.
Provincial Health Services Authority (PHSA) plans, coordinates and evaluates specialized health services with the BC health authorities to provide equitable and cost-effective health care for people throughout the province. Our values reflect our commitment to excellence and include: Respect people - Be compassionate - Dare to innovate - Cultivate partnerships - Serve with purpose. Learn more about PHSA and our programs: jobs.phsa.ca/programs-and-services
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