Clinical Quality Assurance Specialist
We are currently searching for a Clinical Quality Assurance Specialist to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and is on-site in Bethesda, MD.Duties & Responsibilities
- Support the lab’s Quality Management Program under leadership of the Quality Program Manager, to ensure quality throughout all stages of the clinical trial process.
- Plan and conduct GCP sponsor audits (international and domestic) of clinical sites, contract clinical laboratories, and CROs to verify and document compliance status and identify any compliance risks.
- Assess GCP compliance risk areas and develop and implement risk mitigation measures.
- Ensure staff and program compliance with lab’s quality procedures and regulatory requirements.
- Conduct trial master file audits.
- Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
- Serve on working groups in support of broader development and implementation of a QMS.
- Provide support to federal clients in their evaluation and selection of CROs and other clinical and nonclinical service providers supporting lab activities.
- Provide guidance, interpretation and information on GCP-related regulations, standards, and quality systems.
- Develop and implement SOPs, policies, work instructions, and other controlled documents for GCP regulatory compliance.
- Proactively identify areas for improvement, collaborate with QA and GCP staff and seek appropriate resources for the functioning and continuous improvement of the QMS.
- Conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting
- Master’s degree in a related field is preferred.
- Minimum of two (2) years of experience in clinical research with Government, Biotech, Pharma and/or CRO and at least two (2) years of experience in Quality Systems related to GCP.
- Certified quality auditor is preferred.
- Experience auditing clinical CRO’s, clinical sites and investigator sites is required.
- Strong understanding of domestic and international quality and regulatory requirements and ICH/GCP is required.
- Outstanding communication skills (interpersonal, verbal and written).
- Strong experience independently managing complex projects.
- Ability to travel approximately 10% of time.
We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.
The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you’ll get…
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.