Clinical Trials Quality Assurance Associate (Night)

Overview

Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle. Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines & real-time solutions. Our clinical trial support services & consultations are tailored to foster your product and requirements. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process. Minerva Research Solution is looking for dynamic individuals with a passion for ensuring the highest standards in clinical trial data quality assurance. As a key player in our team, you will play a crucial role in maintaining the integrity and accuracy of clinical trial data.

Responsibilities

• Perform comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness
• Ensure data is recorded under sponsor protocol, GCP guidelines, industry guidelines, and agency regulations
• Perform quality control checks; identify and track source documentation errors and non-conformances with requirements
• Provide ongoing compliance support including but not limited to :
• Preparing periodic clinical trial quality reports for assigned programs and assessing these reports with applicable clinical team members to identify areas of risk. Collaborates with applicable team members to develop risk mitigation plans
• Collaborating with the Clinical Team to share audit / inspection observations for lessons learned across protocol, and / or program, and working with appropriate groups to implement Corrective Action Plans (CAPAs)
• Performs quality reviews of key documents developed for use in clinical trials and in preparation for submission to regulatory health authorities
• Assist in preparing for all Sponsor and FDA audits
• Assist in conducting internal audits to review key processes
• Provide appropriate support to assigned cross-functional workgroups
• Establishes effective partnerships with internal staff to facilitate the timely identification and resolution of compliance and quality matters and other opportunities for quality process improvement
• Query resolution and data entry and questionnaire preparation regarding the respective studies
• Other related Quality Assurance projects as assigned
• The QA Associate will report to the Quality Assurance Lead

Knowledge, Education, and Experience

Skills and Abilities

Benefits

Openings

Work Schedule

Monday to Friday; Evening Shift (07 PM to 03 AM); transport facility provided for female staff only and allowance for male employees, additional night shift allowance

Location

Karachi Division, Sindh, Pakistan

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