Social & Scientific Systems (S-3)

Quality Assurance Manager

US-MD-Silver Spring
Job ID
2017-1684
Category
Clinical
Type
Regular Full-Time

Overview

Social & Scientific Systems (SSS) works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. Please join our dedicated staff of employee-owners in an environment that values diversity and supports health, well-being, and professional growth.

Responsibilities

  • Lead all activities of quality assurance
  • Lead the review and development of clinical research protocols and Clinical Quality Management plans (CQMPs).
  • Implement and maintain a viable internal quality compliance function for all activities within the CTC (clinical protocols and lab procedures).
  • Develop internal monitoring plan appropriate for phase, complexity & size of trial.
  • Review and assure Regulatory Files are maintained and complete in accordance with applicable regulations and guidelines.
  • Maintain study records in accord with applicable regulations and guidelines.
  • Facilitate quality assurance monitoring by representatives of government agency or other study sponsors.
  • Facilitate communication between CTC and other quality groups. Contribute to external audits and inspections when appropriate.
  • Review protocol specific source forms; subject, lab & IP prior to use.
  • Discuss deficiencies with staff & recommend modifications as needed.
  • Review documentation of ongoing studies for accuracy & completeness, documenting deficiencies constructively as queries for the CRC and Investigator, providing references as appropriate to improve study implementation practices; with follow through reviewing responses to ensure they are complete and appropriate.
  • Manage Department SOPs: Maintain official & archived documents, table of contents, conduct/oversee biannual review process, write & format SOPs in collaboration with other team members, following institution policy.
  • Recommend appropriate staff training.
  • Maintain and update on-site archive tracking document for all studies conducted at the CTC.
  • Coordinate transfer with the Archivist (or Sponsor) to off-site location.

Qualifications

  • Bachelor's degree and 7-10 years of directly related experience; Registered Nurse with at least 5 years of experience as a CRA preferred or a Master’s Degree in Health Science with 5-7 years of experience
  • CCRC/CCRA certification preferred

Knowledge, Skills and Abilities:

  • Must have excellent verbal and written communication skills; excellent interpersonal and client management skills
  • Strong working knowledge of GCPs, ICH guidelines, FDA and/or EU guidelines
  • Experience with clinical trials management systems
  • Excellent organizational and time management skills
  • Proficiency in all MS-Office applications including Microsoft Word, Excel and PowerPoint, MS Projects a plus.
  • Must possess a professional and customer service oriented demeanor
  • Experience working in matrix environments; ability to work well in a team environment
  • Ability to perform job specific responsibilities with minimal supervision
  • Exercise sound judgment and able to make decisions independently
  • Demonstrate problem solving skills, strong sense of urgency and attention to detail

SSS is committed to fostering a diverse workforce and is proud to be an Affirmative Action/Equal Opportunity Employer of Minorities/Women/Protected Veterans/Individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by law.

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