What are the responsibilities and job description for the Quality Assurance Specialist position at Aqualane Clinical Research?
Company Description
Aqualane Clinical Research is a leading clinical research group that focuses on advancing medical therapies in various human disease states. Through collaboration with patients, care partners, and industry sponsors, we prioritize the safe and ethical study of emerging therapies where there is an unmet need for safety and effectiveness.
Role Description
We are seeking a detail-oriented and experienced on-site QA/QC Specialist to join our dynamic team, FULL TIME, in the clinical research field. The ideal candidate will have a strong foundation in clinical experience and quality assurance/quality control, with a focus on clinical trial monitoring, documentation, and compliance. This position plays a crucial role in ensuring that clinical studies meet regulatory requirements and industry standards.
Key Responsibilities
- Quality Assurance & Control: Oversee and manage quality control activities related to clinical research projects, including ensuring compliance with Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.
- Document Review: Conduct thorough reviews of clinical trial documentation, protocols, and case report forms (CRFs) to ensure accuracy, completeness, and compliance with regulations.
- Audit Support: Perform internal audits to assess the quality of clinical trials and assist in external audits by regulatory bodies.
- Training & Compliance: Provide ongoing training to clinical teams on QA/QC practices and ensure that all team members adhere to regulatory guidelines.
- Risk Management: Identify areas of potential risk in clinical trials, implement corrective actions, and monitor progress.
- Reporting: Prepare and maintain detailed reports of audits, inspections, and quality checks.
Qualifications
- Clinical Experience: At least 2 years of experience in clinical research, clinical trials, or related fields.
- Attention to Detail: Strong ability to identify discrepancies, ensure accuracy, and maintain high standards in clinical documentation.
- Communication Skills: Excellent verbal and written communication skills to collaborate with cross-functional teams and external stakeholders.
- Problem-Solving: Ability to think critically and manage complex tasks in a fast-paced environment.
Preferred Qualifications
- Clinical Research Certification: Certification in Clinical Research (e.g., CCRA, CCRP) is a plus.
- Clinical Research Knowledge: Familiarity with clinical trial processes, data management, and regulatory requirements (FDA, ICH, GCP), is a plus.
- Experience with Electronic Data Capture (EDC): Familiarity with EDC systems (e.g., Medidata, Veeva, etc.) is highly desirable.
Benefits
- Health, Dental, and Vision Insurance
- Paid Time Off
- Opportunities for career growth and development in the clinical research field