Clinical Research Quality Assurance Specialist

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)