Careers
Quality Assurance Manager
Scope
GENERAL SUMMARY OF DUTIES – Review study participant research data to ensure compliance with study protocols and ensure study guidelines are followed in accordance with Good Clinical Practices.
SUPERVISOR – Clinical Operations Manager
SUPERVISES – None
Duties
DUTIES INCLUDE, BUT ARE NOT LIMITED TO:
- Reviewing all patient study research / books to ensure compliance with study protocols and guidelines.
- Responsible for quality assurance and preparation for FDA & sponsor audits.
- Ensure all books are reviewed prior to monitoring visits.
- Ensure correction of any problems noted in research data.
- Attending initiation meetings and other study related meetings as required.
- Identifies and assists in developing training programs for coordinators and research assistants based upon quality assurance review.
- Answering inquiries by staff if protocol questions arise.
- Other duties as assigned.
Qualifications
EDUCATION – Bachelor’s degree in a Science Field required. Master's degree preferred.
EXPERIENCE – At least five (5) years of professional clinical research experience required.
KNOWLEDGE, SKILLS & ABILITIES – This position requires the following minimal requirements:
- Knowledge of clinical trials and study protocols.
- Accuracy, thoroughness and attention to detail imperative.
- Skill in maintaining / reviewing records.
- Skill in developing and maintaining effective working relationships with patients, staff, and the public.
- Ability to work independently as well as within a team.
- Ability to effectively present study information.
- Ability to present a positive image of the clinic.
- Ability to maintain client confidentiality.
- Ability to communicate effectively with peers, physicians and management.
- Ability to communicate clearly both orally and in written form.
- Ability to travel.
CERTIFICATE/LICENSE –Certification in Good Clinical Practices desired. CPR training provided.
