Operational Compliance Associate- Cape Breton, NS

Care Access Research; Nova Scotia; On-site; CAD 60,000 - 100,000; Full time

Job summary

An innovative firm is seeking a dedicated Operational Compliance Associate to enhance quality and compliance at research sites. In this pivotal role, you will ensure data accuracy, oversee compliance with regulatory standards, and implement best practices to preempt quality issues. Your expertise in GCP guidelines and operational compliance will be crucial in supporting the execution of our quality framework. Join a passionate team committed to revolutionizing access to clinical trials and making a difference in patients' lives. If you're ready to contribute to meaningful medical breakthroughs, this opportunity is perfect for you.

Benefits

6 weeks paid vacation annually

Access to group health benefits plan

Voluntary group RRSP retirement plan with matched contributions

Qualifications

• Minimum of 3 years industry experience in clinical research.
• Expert knowledge of GCP guidelines and quality regulations.

Responsibilities

• Oversee data accuracy and quality for research projects.
• Develop dashboard metrics for site recruitment and quality.

Skills

GCP guidelines

Quality regulations

Data quality oversight

Operational compliance

Education

Bachelor's degree in a related field

Job description

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 are not limited to:

1. Oversee the accuracy and quality of data for research projects within a designated research site.
2. Develop, maintain and produce dashboard metrics for site recruitment, participant statuses and operational quality metrics for research projects within a designated research site.
3. Oversee the Data and Quality Processes within a designated site, which include PI Oversight, Delegation Log checks, and SAE reporting tracking.
4. Oversee the implementation of best practices within a designated site to pre-empt quality issues.
5. 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.
6. Collaborate with the Operational Compliance Team for the facilitation and participation of Root Cause Analysis.
7. 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.
8. 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:

1. Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
2. Knowledge and understanding of the industry requirements, best practice, and organization of a clinical research site.
3. 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

Diversity & Inclusion

We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.

At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the physicians and caring for patients.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

Employment Statement

Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.