Clinical Trials Quality Assurance Associate (Night)

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 readinessEnsure data is recorded under sponsor protocol, GCP guidelines, industry guidelines, and agency regulationsPerform quality control checks; identify and track source documentation errors and non-conformances with requirementsProvide 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 plansCollaborating 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 authoritiesAssist in preparing for all Sponsor and FDA auditsAssist in conducting internal audits to review key processesProvide appropriate support to assigned cross-functional workgroupsEstablishes effective partnerships with internal staff to facilitate the timely identification and resolution of compliance and quality matters and other opportunities for quality process improvementQuery resolution and data entry and questionnaire preparation regarding the respective studiesOther related Quality Assurance projects as assignedThe QA Associate will report to the Quality Assurance LeadKnowledge, 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 applyIn-depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trialsKnowledge of IRB requirements1+ 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 plusSkills and Abilities:Good communication skills (interpersonal, written, verbal)Strong attention to detail and good time management skillsFlexible attitude concerning work assignmentsAbility to manage multiple and varied tasks in a fast-moving environmentAbility to interact professionally at all levels within the organizationKnowledge of the HIPAA Privacy Act and its application to clinical researchBenefits:Competitive salary and performance-based bonusesMedical health insurance coverageEmployees Old-age benefits coverageFlexible work hours and remote work optionsProfessional learning and development supportGenerous vacation and paid time offEmployee assistance programs for mental healthCompany-sponsored events and team-building activitiesDiverse, professional, and inclusive work environmentOpportunities for career growthCutting-edge technology and toolsFamily-friendly policies, including parental leaveCommuter benefits or transportation assistanceSocial responsibility and community involvement programsOpenings:04 positionsFull-timeOn-site jobWork Schedule Timings:Monday to FridayEvening Shift (07 PM to 03 AM)(transport facility provided for female staff only and allowance for male employees, additional night shift allowance)Powered by JazzHR6NiakziJjf