Clinical Trial Data Assurance Specialist

Job Title: Clinical Trial Data Assurance Specialist

• We are seeking a detail-oriented and skilled professional to perform comprehensive data-driven quality monitoring activities to ensure compliance with regulatory requirements and SOPs.
• The ideal candidate will ensure that all clinical trial data is recorded under sponsor protocol, GCP guidelines, industry guidelines, and agency regulations.
• This role involves performing quality control checks, identifying and tracking source documentation errors and non-conformances with requirements.
• In this position, you will provide ongoing compliance support, including preparing periodic clinical trial quality reports for assigned programs and assessing these reports with applicable clinical team members to identify areas of risk.
• You will collaborate with the clinical team to share audit/inspection observations for lessons learned across protocols, and/or programs, and work with appropriate groups to implement Corrective Action Plans (CAPAs).
• The successful candidate will also perform quality reviews of key documents developed for use in clinical trials and in preparation for submission to regulatory health authorities.
• You will assist in preparing for all Sponsor and FDA audits, conduct internal audits to review key processes, and provide appropriate support to assigned cross-functional workgroups.
• Establishing effective partnerships with internal staff to facilitate the timely identification and resolution of compliance and quality matters and other opportunities for quality process improvement is essential.
• Additionally, you will resolve queries, enter data, and prepare questionnaires regarding respective studies.
• Other related Quality Assurance projects as assigned will be undertaken by the QA Associate.

Candidate Requirements:

• A qualified professional with a strong medical background (Pharm-D, MBBS, BDS etc) with a keen interest in Clinical Research is highly encouraged to apply.
• The ideal candidate will possess an in-depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials.
• Knowledge of IRB requirements is also necessary.
• A minimum of 1+ years' experience in the Quality Control/Quality Assurance area in clinical research is preferred.
• Experience including external clinical/regulatory and document auditing will be advantageous.

Key Skills and Abilities:

• Excellent 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 is required

• 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

04 positions

Full-time

On-site job

Work Schedule Timings: Monday to Friday Evening Shift (06 PM to 02 AM)

Transport facility provided for female staff only, and allowance for male employees. Additional night shift allowance available.