Research Quality Assurance Manager

Location
Silver Spring, MD
Posted
Nov 16, 2021
Closes
Dec 01, 2021
Ref
229352202111
Function
Accountant, Finance
Industry
Research
Hours
Full Time
Job Summary/Company:

Sparks Group has partnered with a leading healthcare research hospital and is seeking a Research quality Assurance Manager. The Manager is responsible for leading and performing comprehensive audits and monitoring investigator-initiated clinical trials. They will report directly to the Executive Director of Research Regulatory Affairs and potentially supervise a team. If you are looking for a new opportunity that helps you enhance your skill set, apply now

Responsibilities:
  • Manage the Research QA and Post-Approval Monitoring program
  • Plan, coordinate, control, and improve processes and methods to ensure adherence to internal and external quality standards and compliance functions
  • Perform extensive audits and monitoring visits to determine compliance with IRB approved protocols, SOPs, and applicable regulatory requirements
  • Implement a quality assurance strategy for the institution to ensure compliance with all applicable regulatory requirements and makes recommendations
  • Develop training programs consistent with organizational needs and in accordance with current GCP/GMP requirements
  • Serve as an internal resource to principal investigators and provides guidance on developing a comprehensive clinical research regulatory
  • Serve on committees and represent the program with professional organizations

Qualifications/Background Profile:
  • Bachelor's Degree in Healthcare preferred or completion of accredited Nursing (RN), Physician Assistant with focus on clinical research
  • Professional certifications as a CRP, auditor, quality or regulatory professional (CIP) required
  • 5+ years of experience in the pharmaceutical, medical, biotechnology or contract research industry
  • 4+ years in quality assurance/regulatory affairs, auditing, clinical research, data management; experience of applicable GCP and GMP compliance and auditing
  • Knowledge of GCP, ICH regulations and auditing techniques
  • Experience in clinical research management and oversight, including project management in a research setting
  • Proficient with Microsoft Office applications; intermediate to advanced Microsoft Excel skills
  • Attention to detail and the ability to operate with considerable independence to effectively establish priorities and work accurately under time constraints
  • Strong analytical skills to develop and interpret complex reports, and related documentations
  • Detail and Process oriented; ability to build and foster successful working relationships

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Qualified candidates should send their resume AND call Sparks Group for additional details. Please note, resume must include a valid email address in order to be considered. We look forward to discussing your background, your current job search, and your potential career path with Sparks Group!

Sparks Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, pregnancy, citizenship, family status, genetic information, disability, or protect veteran status.