Part-time Qc Reviewer
6 months ago
**General Responsibilities**:
- Handles tasks under direction and guidance
- Perform quality control procedures for clinical trials managed by the Clinical Operations department; review all study documentation for accuracy, consistency and completeness
- Work with QC manager and QC Specialists to ensure study specific QC plans are followed during clinical trials, ensuring QC processes are in alignment with Cliantha SOPs and study protocols
- Assist with the development of; and utilize QC checklists and other QC tools designed to document/track the QC review process
- Communicate findings from QC reviews to the appropriate Clinical Operations staff via QC summaries, reports or verbally as required under the guidance of QC manager/QC Specialists
- As required, follow-up on all QC findings, until a satisfactory resolution has been determined
- Assure documentation review meets or exceeds designated timeline parameters
- Maintain a working knowledge of relevant US, Canadian and European GxP regulations as well as ICH regulations
- Ensuring training file and SOP reading is maintained and up to date
- Ensure compliance with appropriate Cliantha SOP’s, GCP and ICH guidelines
- Participate in training sessions
- Participate in training of staff as experience and qualifications permit
- Work in a safe manner that does not endanger yourself or co-workers
- Execute other duties as may be required by the QC Manager and other members of Cliantha Research Management team as training and experience allow
**Qualifications**:
- High School diploma or equivalent. Prefer a Bachelor degree, with a minimum of two years of college, university, or technical school education in life science or relevant scientific discipline.
- Ability to use computers and software associated with their job function (e.g. Microsoft Excel, Word and Outlook.)
- 0-2 years of relevant experience in a clinical research setting.Strong eye for detail and ability to spot inconsistencies a must.Good conflict management skills.
- Displays a basic ability to identify, anticipate and define issues in a timely manner and to understand the potential impact of issues. Sufficient awareness to notify a supervisor when the problem is beyond the individual’s ability to resolve, or as otherwise appropriate.
- Displays some analytical and problem solving skills and the ability to present solutions.
- Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively.
- Excellent interpersonal skills.
- Strong written and verbal communication skills.
**Job Types**: Part-time, Permanent
Part-time hours: 20 per week
Schedule:
- 8 hour shift
**Experience**:
- Quality Control: 1 year (preferred)
- Clinical Research: 1 year (preferred)
Shift availability:
- Day Shift (preferred)
Work Location: In person
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