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Clinical Trial Quality Assurance Specialist

2 weeks ago

Karachi, Sindh, Pakistan beBee Careers Full time
Quality Assurance Specialist - Data Integrity

We are seeking a detail-oriented and proactive Quality Assurance Specialist to join our team. As a key player in our data integrity process, you will play a crucial role in ensuring the accuracy and reliability of clinical trial data.

About the Role
  • This position is responsible for performing comprehensive quality monitoring activities to ensure compliance with regulatory requirements and standard operating procedures (SOPs).
  • You will evaluate data to ensure it meets sponsor protocol, Good Clinical Practice (GCP) guidelines, industry standards, and agency regulations.
  • Conduct quality control checks, identify and track source documentation errors, and non-conformances with requirements.

The ideal candidate will have a keen eye for detail, excellent analytical skills, and the ability to manage multiple tasks in a fast-paced environment.

Responsibilities
  1. Perform quality monitoring activities to ensure data integrity and compliance with regulatory requirements and SOPs.
  2. Evaluate data to ensure accuracy and consistency with sponsor protocol, GCP guidelines, industry standards, and agency regulations.
  3. Conduct quality control checks to identify and track errors and non-conformances with requirements.
  4. Prepare periodic quality reports for assigned programs and collaborate with the clinical team to assess these reports and identify areas of risk.
  5. Provide ongoing compliance support, including reviewing quality of key documents developed for use in clinical trials and preparing for sponsor and FDA audits.
  6. Collaborate with the clinical team to share audit/inspection observations for lessons learned across protocols and/or programs.
  7. Work with appropriate groups to implement Corrective Action Plans (CAPAs) and assist in conducting internal audits to review key processes.
  8. Establish effective partnerships with internal staff to facilitate the timely identification and resolution of compliance and quality matters.
  9. Resolving queries and entering data related to respective studies.
  10. Other related Quality Assurance projects as assigned.

This is a full-time, on-site position working Monday through Friday, 6 PM to 2 AM.

Requirements
  • A medical graduate with a keen interest in clinical research.
  • In-depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials.
  • Knowledge of IRB requirements.
  • Experience including external clinical/regulatory and document auditing will be a plus.
Skills and Abilities
  • Good communication skills (interpersonal, written, verbal).
  • Strong attention to detail and good time management skills.
  • Flexible attitude with respect to work assignments.
  • Ability to manage multiple and varied tasks in a fast-moving environment.
  • Ability to interact professionally at all levels within the organization.
  • Knowledge of HIPAA Privacy Act and its application to clinical research.
Benefits
  • Competitive salary and performance-based bonuses.
  • Medical health insurance coverage.
  • Employees Old-age benefits coverage.
  • Professional learning and development support.
  • Generous vacation and paid time off.
  • Employee assistance programs for mental health.
  • Company-sponsored events and team-building activities.
  • Diverse, professional, and inclusive work environment.
  • Opportunities for career growth.
  • Cutting-edge technology and tools.
  • Family-friendly policies, including parental leave.
  • Commuter benefits or transportation assistance.
  • Social responsibility and community involvement programs.
Job Description Format

We offer a dynamic and supportive work environment that fosters personal and professional growth. Our team members enjoy competitive salaries, comprehensive benefits, and opportunities for advancement.

We strive to deliver high-quality services to our clients and partners. If you are a motivated and detail-oriented individual who shares our commitment to excellence, we encourage you to apply for this exciting opportunity.

Please note that this job description may be subject to change based on business needs and requirements.