Operational Compliance Associate- Thunder Bay, Ontario

What We Do

Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.

Who We Are

We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.

Position Overview

We are currently seeking a dedicated and clinical research experienced professional for the position of Operational Compliance Associate. As an Operational Compliance Associate, you will play a crucial role in supporting the execution of our operational quality and compliance framework at the Research Site level. Your main objective will be to oversee Operational Compliance at the site level ultimately increasing operational quality, efficiency, and long-term business success.

What You'll Be Working On

Duties include but not limited to:

·       Oversee the accuracy and quality of data for research projects within a designated research site.

·       Develop, maintain and produce dashboard metrics for site recruitment, participant statuses and operational quality metrics for research projects within a designated research site.

·       Oversee the Data and Quality Processes within a designated site, which include PI Oversight, Delegation Log checks, and SAE reporting tracking.

·       Oversee the implementation of best practices within a designated site to pre-empt quality issues.

·       Collaborate with the Operational Compliance Team with the management of quality issues reported in the Care Access Quality Management System specific to a designated site.

·       Collaborate with the Operational Compliance Team for the facilitation and participation of Root Cause Analysis.

·       Complete operational compliance checks on clinical trial records for a designated site ensuring that source data, CRF and ISF records are accurate complete and inspection ready at all times.

·       Ensure designated site staff are compliant with regulatory, client and or Sponsor requirements and or expectations

·       Physical and Travel Requirements

Candidates must be willing to travel between the research sites in Canada. Frequency and length of travel may depend on need.

What You Bring

Knowledge, Skills, and Abilities:

·       Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.

·       knowledge and understanding of the industry requirements, best practice, and organization of a clinical research site.

·       Minimum of 3 years industry experience and have had exposure to internal audits as well as Regulatory inspections.

Certifications/Licenses, Education, and Experience:

·       Minimum of 3 years of industry experience

Benefits

-6 weeks paid vacation annually   

-Access to group health benefits plan for self and dependents   

-Voluntary group RRSP retirement plan with matched contributions