Clinical Research Quality Assurance Specialist
Job Description
Job Description
Salary :
Quality Assurance Specialist
The Quality Assurance Specialist will perform review of multiple trial related activities and documents, to determine whether study activities were recorded, analyzed, and accurately reported, according to the protocol, Standard Operating Procedures and Good Clinical Practice
- Audits all disciplines-Screening, Enrollment, Regulatory, Operations
- Prepares and assists the site for Sponsor Audits and / or Inspections
- Review study protocols, informed consent documents, source documentation and other study-related documentation, to assure conformance with all applicable requirements.
- Identifies and communicates opportunities for process improvement with Training Manager and Study Team
- Maintains necessary documentation of QA records and study files
- Notifies management of observed quality and compliance trends in the areas inspected
- Performs other related duties as assigned
Skills and Abilities :
- Strong analytical and problem-solving skills
- Detail oriented with the ability to perform at a high level of accuracy
- Must handle confidential matters and sensitive information with discretion and judgment
- Ability to handle multiple projects simultaneously and work independently
- Ability to understand and interpret clinical research protocols and other applicable sponsor documents
- Written and oral communication skills
- Organizational skills
- Ability to pay attention to detail
EXPERIENCE :
Minimum 3 years Clinical Research Experience (CCRC or CCRP preferred)
Two years of Clinical Research Quality Assurance or similar clinical research experience or educational equivalent
Strong understanding of FDA, ICH and other regulatory and audit issues in clinical trials and compliance.
An understanding of medical terminology and technical writing
Excellent interpersonal communication, including verbal and written
Proficient in Microsoft Office and possess the ability to learn software programs (e.g., IRB, CTMS, EMR)
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