Quality Assurance Associate, Clinical Trials

Quality Assurance Associate, Clinical Trials

PHSA Corporate

Vancouver, BC

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.

The Quality Assurance Associate, Clinical Trials performs a variety of duties of a knowledge-based nature to execute Quality Improvement projects in collaboration with clinical trials staff and stakeholders.

Reporting to the Quality Lead, Clinical Trials, the Quality Assurance Associate promotes and supports innovations, Quality Improvement ideas and assists in meeting Quality targets.

The Quality Assurance Associate works to ensure Quality Management principles, concepts, tools, and methods are enforced and adhered to for clinical trials and research.

The Quality Assurance Associate interacts with senior management and clinical staff across PHSA to convey information utilizing strong communication abilities and the exchange of information.

Creates reports and documents for internal presentation. Works independently and communicates with the staff in a manner that promotes positive and respectful relationships.

What you’ll do

• Collaborates with various levels of management across PHSA to create organization-specific tools and processes, including the development, review, and editing of work standards, and ensures Quality Management principles, concepts, tools, and methods are enforced and adhered to for clinical trials and research.
• Performs quality reviews of Trial Master Files and clinical trial data entry to ensure quality is maintained consistently throughout the clinical trial lifecycle.
• Collaborates with clinical trial teams to build the trial structure in the CTMS and makes any necessary amendments.
• Establishes and maintains effective communication with all PHSA research organizations to help facilitate the improvement of quality across PHSA's clinical trials by evaluating their practices and completion of tasks on clinical trials, and providing advice / guidance to the clinical trial units and individual teams.
• Maintains departmental databases by collecting data and generating dashboard reports highlighting metrics on patient accrual for individual clinical trials and research performance.
• Performs data entry and trending on submitted items in the Document Management, Nonconformance, and Corrective and Preventive Action (CAPA) systems.

Identifies and assesses regulatory and quality risks in activities and processes as necessary according to regulatory agency guidelines and PHSA quality practices, making recommendations on improvements and corrections

Provides administrative support to clinical trial / research unit staff, such as preparation of a variety of documents including correspondence, reports, meeting agendas, meeting minutes, researching and gathering information, and following up on outstanding action items specific to Quality initiatives.

What you bring

Qualifications

• A level of education, training and experience equivalent to a Bachelor Degree in a field such as public health or health sciences, plus a minimum of one (1) year of recent, related experience in a health care environment such as research, quality improvement or a regulatory environment.
• Excellent organizational skills. Superior interpersonal skills and ability to undertake challenging assignments and work with a diverse group of persons, policies and procedures.

Demonstrated ability to exercise initiative and independent judgment in the performance of duties. Ability to accept responsibility and work independently while at the same time functioning as a strong team player.

Excellent written and oral communication skills. Knowledge of a variety of computer software program including word processing, spreadsheet and database applications.

Knowledge of Health Canada, FDA / ICH-GCP regulations / guidelines.

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.

Salary Range : $57,347 - $75,268 / 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

Closing date : Applications accepted until position is filled

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

Requisition # 167779E

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 () 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 :

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

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-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.