Quality Assurance Associate, Clinical Trials

5 months ago

Vancouver, Canada PHSA Full time

**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.

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).

**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 progr

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