|Job Description Summary:||
The Biostatistics Center of the Milken Institute School of Public Health is an off-campus research facility of The George Washington (GW) University located in Rockville, Maryland. The Biostatistics Center serves as the coordinating center and/or statistical center for multi-center clinical trials and epidemiological studies funded by federal agencies including the National Institutes of Health (NIH). The Biostatistics Center is a leader in the statistical coordination of major medical research programs of national and international scope. Visit our website at: .
The Biostatistics Center's Research Compliance Specialist II serves as Director of Quality Assurance. The position oversees quality assurance functions including, but not limited to, development and maintenance of quality assurance programs and policies, oversight of inspections and audits, as well as management of the Quality Documents.
Duties most typically performed by this position include utilizing relevant professional experience and judgment for the following:
- Developing, implementing, and maintaining an internal audit monitoring system and schedule.
- Leading the ongoing development, management, and implementation of written processes for the effective management of clinical trials.
- Leading the reporting of trends and metrics from all clinical activities to aide in effective process improvement and risk control.
- Maintaining Standard Operating Procedures (SOPs) including periodic review and coordination of the initiation/revision of procedures and policies to ensure compliance with new/revised regulations and guidelines
- Ensuring quality incidents are investigated, root cause analysis is performed and that CAPA has been implemented and monitored for effectiveness.
- Performing Quality Documents review and approval (e.g. SOPs, guidance documents)
- Partnering with study teams to identify potential changes and opportunities for process improvement.
- Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents and study protocols.
- Educating and mentoring research team with interpretation of regulatory requirements (e.g., GCPs), SOP requirements, and other guidance documents, as applicable.
- Evaluating responses to monitoring and audit reports with the research team; follow-up with applicable stakeholders to ensure resolution.
- Conducting feasibility assessments, ongoing quality assurance reviews of clinical research studies, with the goal of assessing site readiness and developing site specific education and processes as needed.
- Reporting quality assurance trends/metrics to Sr. Management.
- Performs other work-related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
Qualified candidates will hold a Bachelor's degree in an appropriate area of specialization plus 7 years of relevant professional experience, or, a Master's degree or higher in a relevant area of study plus 5 years of relevant professional experience. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.
|Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications:|
Excellent verbal and written communication skills.
|Typical Hiring Range||Commensurate with Experience.|
|Campus Location:||Rockville, Maryland|
|Hours Per Week:||40|
|Work Schedule:||Monday - Friday, 9am - 5pm|
|Will this job require the employee to work on site?||No|
|Employee Onsite Status||Hybrid|
|Required Background Check:||Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search|
|Special Instructions to Applicants:||
Employer will not sponsor for employment Visa status
|Internal Applicants Only?||No|
|Job Open Date:||01/25/2023|
|Job Close Date:|
|If temporary, grant funded or limited term appointment, position funded until:|
|Background Screening||Successful Completion of a Background Screening will be required as a condition of hire.|
The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.