Operational Compliance Associate
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Job Description
Operational Compliance Associate supporting operational quality and compliance framework at research sites. Overseeing accuracy of data and best practices in clinical trials for Care Access.
Responsibilities:
- 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
Requirements:
- 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.
Benefits:
- PTO/vacation days, sick days, holidays.
- LuxMed
- PPK Plan
- Life Insurance
- Health & Wellness Allowance
- Car Allowance
- Quarterly bonus system based on achieving individual goals
- Culture of growth and equality
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