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Operational Compliance Specialist

1 tydzień temu

Warszawa, Mazovia, Polska Care Access Pełny etat

About Us

Care Access is a pioneering organization at the forefront of clinical research, dedicated to revolutionizing access to life-changing therapies for patients worldwide. Our mission-driven team comprises physician investigators, nurse coordinators, and operations managers working together as one connected unit.

Our Vision

We strive to engage every healthcare professional in clinical research, making trials a care option for every patient. By removing bottlenecks, we accelerate the approval and delivery of critical and life-saving therapies.

The Role

We are seeking a skilled Operational Compliance Associate to support our operational quality and compliance framework at the Research Site level. As an integral part of our team, you will oversee Operational Compliance at the site level, ensuring operational quality, efficiency, and long-term business success.

Key Responsibilities

  1. Data Accuracy and Quality: Oversee the accuracy and quality of data for research projects within a designated research site.
  2. Dashboards and Metrics: Develop, maintain, and produce dashboard metrics for site recruitment, participant statuses, and operational quality metrics for research projects within a designated research site.
  3. Data and Quality Processes: Oversee Data and Quality Processes within a designated site, which include PI Oversight, Delegation Log checks, and SAE reporting tracking.
  4. Best Practices Implementation: Oversee the implementation of best practices within a designated site to pre-empt quality issues.
  5. Quality Issue Management: Collaborate with the Operational Compliance Team for the management of quality issues reported in the Care Access Quality Management System specific to a designated site.
  6. Root Cause Analysis: Collaborate with the Operational Compliance Team for the facilitation and participation of Root Cause Analysis.
  7. Compliance Checks: 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. Staff Compliance: Ensure designated site staff are compliant with regulatory, client, and Sponsor requirements and expectations.

Requirements and Qualifications

  1. GCP Guidelines: Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
  2. Industry Knowledge: Knowledge and understanding of industry requirements, best practice, and organization of a clinical research site.
  3. Experience: Minimum of 3 years industry experience and have had exposure to internal audits as well as Regulatory inspections.

Benefits

  1. Paid Time Off (PTO) and vacation days
  2. Sick days and holidays
  3. 100% paid medical, dental, and vision Insurance
  4. HSA plan
  5. Short-term disability, long-term disability, and life Insurance
  6. Culture of growth and equality
  7. 401k retirement plan

Diversity & Inclusion

Care Access is committed to fostering a diverse and inclusive culture where everyone feels valued and respected. We believe that unique contributions drive our success and advance our mission to provide access to clinical trials for patients worldwide.