Quality Assurance Associate, Clinical Research, Clinical Trials Hub - Vancouver, Canada - BC Childrens Hospital

Description

Quality Assurance Associate, Clinical Research, Clinical Trials Hub

BC Children's Hospital

Vancouver, BC

What you'll do

• Conduct independent internal audits of clinical trials and clinical research unit teams, including preparing audit reports, and discussing findings with the clinical research team. Identify when non-compliance has occurred and takes immediate action if necessary due to findings.
• Work in collaboration with various levels of management within the Clinical Research Quality Office to create Quality Assurance tools and processes, including the development, review, and editing of Standard Operating Procedures (SOPs), and ensures Quality Management principles, concepts, tools, and methods are enforced and adhered to for clinical trials and research. Recommend revisions to Clinical Research SOPs based on experience and observations and present recommendations to Management.
• Establish and maintain effective communication with all clinical research units to help facilitate the improvement of quality across BC Children's clinical trials by evaluating their practices and completion of tasks on clinical trials and providing advice/guidance to the clinical research units and individual teams.
• Participate in the development and evaluation of competencies for clinical research personnel in collaboration with the Quality Assurance and Process Improvement Specialist. Prepare guidance documents, toolkits and templates for clinical research staff. Identifies and make appropriate changes to training and materials as required based on audit findings, peer feedback and observations. Provide training and education to clinical research unit staff as required.
• Collaborate with Quality staff in other organizations and Health Authorities to ensure consistency in application of SOPs and provides assistance in rollout and execution of the quality systems.
• Perform data entry and trending on submitted items in the Document Management, Nonconformance, and Corrective and Preventive Action (CAPA) systems. Identify and assess 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.
• Provide administrative support to the Clinical Research Quality Office 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.
• Participate in investigation activities associated within the overall Quality Assurance system and collects data for Quality initiatives by administering questionnaires and extracting data from the Clinical Trial Management System as directed.
• Coordinate regulatory inspections and assists in preparing and training clinical research teams for FDA/Health Canada/cooperative group inspections as necessary.
• Track clinical research unit staff's completion of training delivered by the Clinical Research Quality Office.

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.

You will also have

• 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.
• Commitment to upholding the shared responsibility of creating lasting and meaningful reconciliation in Canada as per TRC and BC's Declaration on the Rights of Indigenous Peoples Act
• Knowledge of social, economic, political and historical realities impacting indigenous communities and familiarity with Indigenous Cultural Safety and anti-racism and accompanying reports (BC DRIPA, TRC, 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.

Job Type: Temporary, Full-Time (until March 31 st 2025)
Salary Range: $55,677 - $73,076/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: 4500 Oak Street, Vancouver BC, V6H 2N9
Applications will be accepted until position is filled.
Hours of Work: Monday - Friday,
Requisition # 161839E

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

BC Children's Hospital (BCCH) provides care for the most seriously ill or injured children and youth from across British Columbia.

BCCH is part of the Provincial Health Services Authority (PHSA).

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:

PHSA and BCCH are committed to employment equity, encouraging all qualified individuals to apply. We recognize that our ability to provide the best care for our diverse patient populations relies on a rich diversity of skills, knowledge, background and experience, and value a safe, inclusive and welcoming environment.

Reconciliation is an ongoing process and a shared responsibility for all of us. The BC Governments' unanimous passage of the Declaration on the Rights of Indigenous Peoples Act was a significant step forward in this journey-one that all health authorities are expected to support as we work in cooperation with Indigenous Peoples to establish a clear and sustainable path to lasting reconciliation. True reconciliation will take time and ongoing commitment to work with Indigenous Peoples as they move toward self-determination. Guiding these efforts Crown agencies must remain focused on creating opportunities that implement the Truth and Reconciliation Commission Mandate.

ATTN: PHSA Employees:

To be considered as a PHSA employee (internal applicant) for this position, you must apply online via your internal profile at

Please note the internal job posting will no longer be accessible after the expiry date of March 29, 2024. If the internal job posting has expired, please contact the Internal Jobs Help Desk and advise that you would like to be considered as a late internal applicant for this position. Please do not apply for the external job posting.

If you have not registered your internal profile, a password is required to log in for the first time. To obtain your password, please contact the Internal Jobs Help Desk at or . Please note regular business hours are Monday - Friday (excluding stats), 8:30am to 4:30pm. For inquiries outside of regular business hours, please email the Internal Jobs Help Desk at and a Help Desk Representative will contact you the next business day.