Essential Job Functions:

• Attend all SIVs (as required)

• Assist QA Director in reviewing source doc templates prior to use, to ensure protocol requirements are followed.

• Review study docs for accuracy and compliance under the guidance of the Quality Assurance Director.

• Ensure data is recorded in accordance with sponsor protocol, GCP guidelines, industry guidelines and agency regulations.

• Perform quality control checks; identify and track source documentation errors and non-conformances with requirements.

• Assist in the preparation of reports for submission to regulatory authorities.

• Serve as resource to Research Assistants in tasks related to quality control.

• Assist QA Director in ensuring the study team addresses all monitoring reports appropriately.

• Work with the site’s regulatory department to accumulate accurate information for generating notes to file and for timely submission to IRB.

• Assist in preparing for all Sponsor and FDA audits,

• Assist in conducting internal audits to review key processes within HRI.

• 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.

• Other related Quality Assurance projects as assigned.

Knowledge, Education, and Experience:

• Minimum Education Required – Bachelor’s Degree

• In-depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials

• Knowledge of IRB requirements

• 3 plus years in work related to Quality Control / Quality Assurance area in clinical research.

• Experience including external clinical/regulatory and document auditing desirable.

Skills and Abilities:

• Good communication skills (interpersonal, written, verbal)

• Strong attention to detail and good time management skills

• Flexible attitude with respect to work assignments

• Ability to manage multiple and varied tasks in a fast-moving environment

• Ability to interact professionally at all levels within the organization.

• Knowledge of HIPAA Privacy Act and its application to clinical research

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