JOB DESCRIPTION:
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 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.
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 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: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)
