Operational Compliance Specialist

7 dni temu


Warszawa, Mazovia, Polska Care Access Research Pełny etat

About Care Access Research

Care Access Research is a pioneering, multi-specialty network of research sites that operates as one cohesive team of physician investigators, nurse coordinators, and operations managers. Our mission is to break down barriers in clinical research, making it an integral part of standard patient care.

Our Goal

We aim to engage every healthcare professional in clinical research and make life-saving therapies accessible to patients worldwide. By streamlining clinical trials, we accelerate the approval and delivery of critical treatments.

Job Description: Operational Compliance Associate

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

Main Responsibilities

  1. Data Oversight: Ensure the accuracy and quality of data for research projects within a designated research site.
  2. Dashboard Development: Create and maintain dashboard metrics for site recruitment, participant statuses, and operational quality metrics for research projects within a designated research site.
  3. Quality Processes: Oversee Data and Quality Processes within a designated site, including PI Oversight, Delegation Log checks, and SAE reporting tracking.
  4. Best Practices Implementation: Implement best practices within a designated site to prevent quality issues.
  5. Collaboration: 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: Participate in Root Cause Analysis facilitated by the Operational Compliance Team.
  7. Compliance Checks: Conduct operational compliance checks on clinical trial records for a designated site, ensuring source data, CRF, and ISF records are accurate, complete, and inspection-ready at all times.
  8. Regulatory Compliance: Ensure designated site staff adhere to regulatory, client, and sponsor requirements and expectations.

Required Skills and Qualifications

  1. GCP Guidelines: Expert knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
  2. Industry Knowledge: Understanding of industry requirements, best practices, and organization of a clinical research site.
  3. Experience: Minimum of 3 years of industry experience, with exposure to internal audits and Regulatory inspections.

Benefits

  • Paid Time Off (PTO): Vacation days, sick days, holidays.
  • LuxMed: Comprehensive health insurance.
  • PPK Plan: Employee stock purchase plan.
  • Life Insurance: Life insurance coverage.
  • Health & Wellness Allowance: Reimbursement for health-related expenses.
  • Culture of Growth and Equality: A culture that values diversity, equality, and growth opportunities.

Diversity and Inclusion Statement

Care Access Research serves patients and researchers from diverse cultures and communities worldwide. We strive to build a team representing the people we aim to support. We value diversity and believe that unique contributions drive our success.



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