Clinical QA Specialist
Dallas Texas
Clinical stage pharmaceutical company building out CPO team! Located in greater Dallas area, this team's culture and pipeline are globally raved about!
RESPONSIBILITIES:
- Collaborate with Quality Assurance on planning and conduct of internal audits, mock audits and inspection activities. Assist with document readiness and logistical preparations by assisting providing all necessary files, conducting review of the files and providing trend information, as required in support of audits and inspections.
- Support CPO to ensure continuous inspection readiness through a review and reconciliation of documents and records, providing support for readiness training and preparedness activities with CPO team. Identify areas for improvement and assist with development of plans to ensure inspection readiness preparedness. Support an environment of continuous inspection readiness through ongoing collaboration with CPO teams to encourage proactive preparation, maintenance and reconciliation clinical study documentation.
- Support CPO study teams/functions by providing guidance during and in drafting responses and Corrective and Preventative Action Plans (CAPAs) to internal and/or external audits, quality events and site non-compliance. Assist with story boards for studies that aid in producing complete study documentation, in conjunction with CPO.
- Monitor investigator compliance by reviewing data and metrics from monitoring reports, protocol deviations and overall compliance. Assist CPO with identification of trends, management and resolution of investigator non-compliance and root cause analysis. Propose corrective and preventative actions and assist with mitigation and resolution activities.
- Create documentation, such as plans, timelines, progress reports to measuring oversight compliance and quality communications.
- Identify and highlight risks and issues within and across studies and escalate appropriately.
- Support the conduct of SOP assessments and gap analysis to improve efficiency and avoid non-compliance.
- Assist with the review and development of Standard Operating Procedures (SOPs), study templates and plans to develop new and improve existing standard procedures and study processes.
- Support the conduct of internal process reviews to assess CPO compliance to procedures and study processes and plans. Collaborate with clinical trial teams to assist in rectifying operational issues, inefficiencies and/or providing opportunities for improvements in study execution.
- Monitor standard CPO reports, tools and trackers to identify and report on deviations from processes. Assist with the implementation of mitigation plans to resolve and avoid deficiencies.
- Review CPO compliance , identify and escalate training gaps and assist in remediation plans to resolve noncompliance.
- Support collaboration between Quality Assurance and CPO on areas of process improvement, inspection readiness and overall compliance to process and regulation.
- Review protocol deviation data and metrics. Assist in the corrective and preventative action planning with CPO team.
- Review standard reports and trackers for monitoring compliance to the requirements for safety oversight and site safety reporting.
- Conduct TMF audits to assess the quality, completeness, timeliness and oversight of TMF in accordance with SOPs and plans.
- Provide support to CPO in the areas of clinical study conduct and compliance oversight and recommendations for improvement of clinical operations activities operational processes.
- Remain current with global regulatory requirements and informed of changes to ensure continual compliance.
- Lead or participate in cross-functional strategic, process improvement, quality and compliance initiatives.
- Provide support, oversight, guidance and subject matter expertise in compliance, process improvement and inspection readiness.
- Provide support to other clinical operations activities as required.
REQUIREMENTS/QUALIFICATIONS:
- Bachelor's degree with a major/ focus in scientific discipline or equivalent
- Minimum of 4 years of relevant experience
- Strong understanding of clinical trial processes
- Knowledge of the drug development process relevant to the pharmaceutical/biotech industry
- Strong understanding of global regulatory and compliance requirements for clinical research, including but not limited to US Code of Federal Regulations (CFR), EU Directive, ICH GCP and Global Data Protection Regulation (GDPR).
- Prior experience in site management and monitoring of investigative sites
- Prior experience working with a CRO is encouraged
- Excellent communication, organization, interpersonal and business skills
- Strong influence, negotiation, analytical conflict resolution and problem-solving skills
- Ability to work effectively with teams
- Embody a culture of improvement and innovation
If interested, apply promptly! The market and process are moving quickly!