Quality Assurance Associate, Clinical Research - Vancouver, Canada - PHSA

PHSA

Verified Company

Vancouver, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

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 noncompliance 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.
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 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 antiracism 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 provincewide 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 inhouse training programs, including +2,000 courses, such as our San'yas Indigenou