Clinical Trials Quality Assurance Associate (Night)

Clinical Trials Quality Assurance Associate (Night)

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

Qualified Profession with strong medical background (Pharm-D, MBBS, BDS etc) with a 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

1+ years in work related to Quality Control / Quality Assurance area in clinical research will be preferred

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 concerning 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 the 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

Flexible work hours and remote work options

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

4 positions

Full-time

On-site job

Work Schedule Timings

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)

Powered by Jazz HR

3c B5v ELh0B

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Internet Publishing

Referrals increase your chances of interviewing at Minerva Research Solutions by 2x

Get notified about new Quality Assurance Associate jobs in

Karāchi, Sindh, Pakistan

.

Karachi Division, Sindh, Pakistan 3 days ago

Assistant Manager Supplier Quality Assurance

Karachi Division, Sindh, Pakistan 4 months ago

Software Quality Assurance Manager - Automation

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr