PHSA: Clinical Trials Monitor, Research Administration & Academic Services

Provincial Health Services Authority (PHSA).
Published
20 June 2024
Location
Vancouver, BC
Closing Date
Applications will be accepted until position is filled.

Description

Job Type: Regular, Full-Time

Salary Range: $67,861 - $97,550 /year. The starting salary for this position would be determined with consideration of the successful candidate’s relevant education and experience, and would be in alignment with the provincial compensation reference plan. Salary will be prorated accordingly for part time roles.

Location: 1333 W Broadway, Vancouver, BC V6H 1G9

Hours of Work: 08:00 – 16:00 (Monday to Friday)

Requisition Number: 167792E

 

In accordance with the Purpose, Vision, Values and Coast Salish Teachings, and strategic directions of PHSA, safety, including both patient and employee safety, is a priority and a responsibility shared by everyone at PHSA. As such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.

Reporting to the Quality Lead, Clinical Trials, the Clinical Trials Monitor provides consultation and advice in support of quality, safety, and performance improvement for all clinical trials evaluation where no external monitor is in place and ensures compliance with all applicable regulations. The Monitor liaises with clinical trial sponsors and investigators and monitors and analyses study data. Monitors and enhances accrual to the trials and ensures effective communication with physicians, investigators and study teams.

 

What you’ll do

  • Ensures adherence to Clinical Trial SOPs, tools and methods.
  • Conducts 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 physicians, investigators and Quality Lead, the Clinical Trials Monitor prepares and implements clinical trial monitoring plans.
  • Conducts onsite and remote monitoring activities to ensure that clinical trials comply with the requirements of the protocol, relevant SOPs and regulatory requirements. Reviews investigator files for completeness and accuracy. Confirms and reviews completed CRF and de-identified source documents. Documents all findings in report format with identification of issues requiring follow up to the Investigator.
  • Designs, develops, tests and maintains the study database based on requirements of the study protocol, investigator and statistician. Ensures the security of database and authorizes access to the study database for other users.
  • Ensures 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.
  • Provides ongoing review of patient accrual to individual clinical trials.
  • Ensures data confidentiality, integrity and security by following established policies, procedures and professional standards of practice for assigned work.
  • Attends and participates 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

Qualifications

  • A level of education, training, and experience equivalent to a Bachelor’s degree in a related health science plus a minimum of three 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.
  • Demonstrated knowledge and working experience of administering clinical trial practices and protocols
  • Demonstrated ability to organize and prioritize workload
  • Demonstrated ability to function as a team member, motivator, facilitator and provide effective consultation
  • Demonstrated ability to operate related equipment and ability to work with all related software.

Skills & Knowledge

  • Commitment to upholding the shared responsibility of creating lasting and meaningful reconciliation in Canada as per TRC (2015) and BC's Declaration on the Rights of Indigenous Peoples Act (2019).
  • As a strong asset for consideration, we are looking for our successful candidate to have: Knowledge of social, economic, political and historical realities of settler colonialism on Indigenous Peoples and familiarity with addressing Indigenous-specific anti-racism, anti-racism and Indigenous Cultural Safety and foundational documents and legislative commitments (The Declaration Act, the Declaration Action Plan, TRC, IPS, Remembering Keegan, etc.).

What we bring

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.

  • Join one of BC’s largest employers with province-wide programs, services and operations – offering vast opportunities for growth, development, and recognition programs that honour the commitment and contribution of all employees.
  • Access to professional development opportunities through our in-house training programs, including +2,000 courses, such as our San’yas Indigenous Cultural Safety Training course, or Core Linx for Leadership roles.
  • Enjoy a comprehensive benefits package, including municipal pension plan, and psychological health & safety programs and holistic wellness resources.
  • Annual statutory holidays (13) with generous vacation entitlement and accruement.
  • PHSA is a remote work friendly employer, welcoming flexible work options to support our people (eligibility may vary, depending on position).
  • Access to WorkPerks, a premium discount program offering a wide range of local and national discounts on electronics, entertainment, dining, travel, wellness, apparel, and more.

As per the current Public Health Order, full vaccination against COVID-19 is a condition of employment with PHSA as of October 26, 2021.

 

What we do

The Provincial Health Services Authority (PHSA) plans, manages 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

PHSA is committed to equity in our hiring and employment practices. With learning and compassion, we are addressing existing inequities and barriers throughout our systems. PHSA is seeking to create a diverse workforce and to establish an inclusive and culturally safe environment. We invite applications and enquiries from all people, particularly those belonging to the historically, systemically, and/or persistently marginalized groups identified under the B.C. Human Rights Code.

One of PHSA’s North Star priorities is to eradicate Indigenous-specific racism, which includes dismantling barriers to health care employment at every level. We welcome Indigenous individuals to apply and/or contact the Sanya'kula Team (Indigenous Recruitment & Employee Experience) for support at indigenous.employment@phsa.ca.

Indigenous-specific anti-racism initiatives are rooted in addressing the unique forms of discrimination, historical and ongoing injustices, and marginalization faced by Indigenous peoples. These initiatives align with an Indigenous rights-based approach, recognizing the inherent rights and self-determination of Indigenous communities. PHSA must uphold legislative obligations and provincial commitments found in the foundational documents such as including Truth & Reconciliation Commission’s Calls to Action (2015), In Plain Sight (2020), BC's Declaration on the Rights of Indigenous Peoples Act (2019), United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), Reclaiming Power and Place Missing and Murdered Indigenous Women & Girls Calls for Justice (2019), the Declaration Act Action Plan and Remembering Keegan: A First Nations Case Study.