Job Description
job Code
#4878
Title
Clinical Trials Documentation AUDIT ANALYST
Date Posted
09/28/2017
Job Type
Direct Hire
Job Location
Connecticut
Salary
73,000.00
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Clinical Trials Documentation AUDIT ANALYST

REGULATORY PROTOCOL AUDIT ANALYST

 

  • Conduct clinical research monitoring and auditing clinical documentation supporting various clinical trials from the pre-award stage through the lifecycle of the study once awarded.
     
  • Works directly Clinical Investigation leadership, and the IRB to facilitate the review of activities associated with human subject research in terms of safety, compliance, and integrity of clinical trials being conducted.

 

  • Evaluates clinical trial conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and Guidelines to Good Clinical Practice.

 

  • Serves as liaison between the investigator, the research team and the FDA during an actual inspection.

 

  • Records proceedings and summarizes inspection activity in real time.

 

  • Consults with investigators needing data safety monitoring plan details/information for their grant application.

 

  • Develops Data and Safety Monitoring Plans based on the risk assignment categories.

 

  • Provides direction to investigators to strengthen their research and ensure regulatory and protocol compliance.

 

  • Analyzes protocol to customize audit plans for protocol specific benchmarks in addition to standard audit reviews.

 

  • Assesses audit findings in the context of the larger program to identify trends or program wide areas of in need of improvement or education.

 

  • Assesses the risk and stratify the study from a QA/regulatory compliance perspective based on clinical research experience and regulatory knowledge.

 

  • Reviews medical records of study participants, determines the impact of non-compliance (e.g. violations of federal regulations, GCP ) on study plans/processes, makes judgments and communicates findings to investigators.

 

  • Exercises judgment in the assessment of the level of risk associated with findings in terms of the need for reporting out to other regulatory entities.

 

  • Reports Quality Assurance findings related to deviations, non-compliance based on very strict reporting regulations.

 

  • Reviews reports/findings from audits with investigators and advises and monitors appropriate action plan.
  • Conducts follow-up reviews for compliance with audit recommendations, responding to investigator rationale.

 

  • Designs and conducts training programs, makes recommendations for quality improvement and assists in the creation and follow up of corrective action plans based on audit findings.

 

  • Integration of Data Safety and Monitoring Plans and Quality Assurance findings with committees and educational plans.

 

REQUIRED SKILLS

  • Bachelor Degree in Science, Healthcare Administration or related field.
  • 5 years of healthcare compliance, quality, risk and/or FDA regulations.
  • Demonstrated ability to exercise good judgment for discretionary and confidential information and possess strong critical thinking skills and problem solving abilities.
     
  • Experience with International conference on Harmonisation (ICH) and
  • Good Clinical Practice (GCP) guidelines.
 
  • Demonstrated ability to be detail oriented while still seeing the “big picture” within the context of a solution-oriented approach to issues.
  • Demonstrated knowledge of federal regulations governing human subject research and federal reporting requirements.
  • Understanding of clinical research review, approval and Data and Safety Monitoring processes.

 

  • Knowledge of federal regulations concerning the protection of human subjects and clinical trials.

 

  • Knowledge of auditing and monitoring techniques.

 

 
  • Demonstrated knowledge of federal regulations governing human subject research and federal reporting requirements.
  • Understanding of clinical research review, approval and Data and Safety Monitoring processes.
  • Knowledge of federal regulations concerning the protection of human subjects and clinical trials.
  • Knowledge of auditing and compliance
  • Education, training instructions regarding compliance and development of corrective actions plans
  • Certifications: GCP, ICH , IRB Preferred.

 


Full time Opportunity-Hamden, CT

Send resume to Krisha Morander, CPC, Email:KrishaM@JMorrissey.com