Quality Assurance Associate (Clinical Trial)Evening Shift

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.

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

• 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 aim to deliver high-quality data and solutions to make your clinical trials a success.
• We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process.
• 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 in accordance with 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.
• Provides 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: Fresh MBBS with keen interest in Clinical Research are strongly encouraged to apply.
• 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.

Openings

03 positions (Night shift) Full-time On-site job Work Schedule Timings: Monday to Friday 7 PM to 3 AM (transport facility provided for female staff only and allowance for male employees, additional night shift allowance)