Clinical Research Compliance Specialist

Jul 10, 2021
Aug 14, 2021
Analyst, Research
Full Time
Under the direction of the Research Quality Assurance (QA) Manager, Clinical Research Compliance Specialist will schedule, prepare for and conduct audits of clinical trials conducted at Children's National Health System and affiliated sites. The Clinical Research Compliance Specialist will assess research participant safety, data integrity and research compliance with applicable institutional standard operating procedures (SOP), Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations and guidances. Job tasks include reviewing Institutional Review Board (IRB), FDA and other study regulatory documentation for accuracy and completeness; comparing research data with source documentation for accuracy and integrity; performing investigational product review and accountability; then synthesizing the information to provide written and verbal feedback to research teams and institutional leadership. The individual will serve as a regulatory affairs and compliance resource to Children's National Research stakeholders, providing support in various Quality Assurance Program functions. Under the guidance of the Research Quality Assurance (QA) Manager, the Clinical Research Compliance Specialist will implement research quality assurance, and risk assessment and reduction strategies to ensure research compliance. Activities could include developing and revising audit plans, audit tools and standard operating procedures; organizing and delivering individual and group education programs; and other activities as assigned. The role requires at least three years substantive experience with Phase I though Phase III trials at the Clinical Research Coordinator, Source Data Verification Monitor, Research Compliance Specialist or IRB Reviewer level.


Minimum Education
Bachelor's Degree Bachelor's Degree or Masters Degree in a scientific discipline or in research administration preferred .

Minimum Work Experience
3 years Work requires at least three years of experience implementing and/or overseeing Phase I through Phase III trials to acquire the skills necessary to audit human subject's research.

Preferred previous experience with investigator-initiated or pharma-sponsored clinical trials in one of the following capacities is strongly desired: lead research coordinator, program manager, clinical research monitor, regulatory coordinator or IRB reviewer. .

Required Skills/Knowledge
Analytical, communication and organizational skills generally acquired through completion of a bachelor's degree program and experience reviewing, leading and/or overseeing clinical research. Ability to work well with diverse, goal-driven colleagues to achieve research compliance while minimizing administrative burden. Computer Skills -proficiency with Excel, Word, Outlook, Access, & PowerPoint; along with cloud-based electronic medical record and data base programs.

Required Licenses and Certifications
Internal candidates should possess one of the following research certifications: • Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA).
• Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP)
• Certified Clinical Research Associate (CCRA) through the Association of Clinical Research Professionals (ACRP)
• Certification in Healthcare Research Compliance (CHRC) through the Health Care Compliance Association (HCCA)

External candidates will be required to obtain a appropriate research certification (e.g., CCRP, CCRC, CCRA or CHRC) within one year of hire. .

Functional Accountabilities

Responsible Conduct of Research
  • Demonstrates consistent adherence to the standards for responsible conduct of research.
  • Complies with and maintains current documentation of all job-related certifications and training
  • Maintains and shares intimate knowledge of institutional SOPs, GCP, ICH, FDA and OHRP regulations and guidance documents.

Quality Assurance Program Auditing
  • Conducts research compliance audits within established program timeframes, in accordance with institutional standard operating procedures (SOP), Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations and guidance documents.
  • Authors accurate, detailed audit reports that document compliance findings and provide regulatory citations.
  • Follows up with auditees to ensure that audit responses and corrective and preventative action plans (CAPA) are provided in a timely manner, allowing for audit closure.
  • Manages multiple, complex activities while maintaining close attention to detail and not losing sight of the institution's research mission.
  • Demonstrates formal and informal leadership in a diverse professional environment.
  • Collaborates with interdisciplinary teams to identify and resolve research compliance challenges.
  • Presents negative information and provides compliance resources to stakeholders in a collegial and educational manne

Educational Support and Training
  • Stays informed of current institutional policies, federal regulations and guidances, and internal and external audit findings involving human subject's research and the use of protected health information (PHI).
  • Provides current and accurate compliance information and resources to the research community.
  • Works well with research stakeholders, appreciating differing skill sets and other workplace diversities while seeking appropriate input.
  • Attends meetings (which could include overnight travel) as requested.
  • Provides information and services to help research with FDA inspection readiness.

Childrens National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

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