Company Description
Hassman Research Institute (HRI) is a leading clinical research organization conducting studies in a wide variety of therapeutic areas. HRI's highly trained and experienced staff are dedicated to maintaining the highest standard of quality in the trials they conduct.
Job Description
Essential Job Functions:
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Assist QA Director in reviewing source doc templates prior to use, to ensure protocol requirements are followed.
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Ensure data is recorded in accordance with sponsor protocol, GCP guidelines, industry guidelines and agency regulations.
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Perform quality control checks; identify and track source documentation errors and non-conformances with requirements.
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Serve as resource to Research Assistants in tasks related to quality control.
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Assist QA Director in ensuring the study team addresses all monitoring reports appropriately.
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Work with the site’s Regulatory Department to accumulate accurate information for generating notes to file and for timely submission to IRB.
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Assist in preparing for all Sponsor and FDA audits,
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Assist in conducting internal audits to review key processes within HRI.
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Assist with the maintenance and retention of training and certification records. Ensure SOP/WI training documents are kept on file and up to date, as per company policies.
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Other related Quality Assurance projects as assigned.
Qualifications
Knowledge, Education, and Experience:
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Minimum Education Required – Bachelor’s Degree
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In depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials
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Knowledge of IRB requirements
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Knowledge of HIPAA Privacy Act and its application to clinical research
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3 plus years in work related to Quality Assurance area in clinical research.
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Experience including external clinical/regulatory and document auditing desirable.
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Ability in the administration, and interpretation of protocols as directed by sponsor
Additional Information
All your information will be kept confidential according to EEO guidelines.
