Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
- As a Compliance Specialist, you will execute quality and compliance processes across the organization. Your responsibilities will include:
- Facilitating the tracking and reporting of quality and compliance activities
- Maintaining tools and materials and providing expertise to advance the vision of the department
- Investigating and resolving issues, monitoring metrics, and maintaining reports and documentation associated with quality and compliance activities
- Managing quality and compliance activities, ensuring they are carried out thoroughly and brought to a successful finish
- Coordinating smaller projects and process/quality improvement initiatives with proven results
- Communicating with representatives from other departments to ensure quality and timelines are maintained regarding compliance activities (e.g., client audits, CAPA, and procedural documents)
- Mentoring staff and serving as a team lead for group projects or process improvement initiatives
- Qualifications
- Bachelor's degree in a related field or equivalent formal academic/vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- Experience with clinical project coordination, clinical project administrator or similar experience is required
- Able to go onsite to the Austin, Texas office 1-3 times per month, so must be within drivable distance to Austin, Texas
- Client facing experience is preferred
- Requirements
- Excellent oral and written communication skills
- Strong organizational and time-management skills
- Firm knowledge of the clinical trial process
- Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines
- Effective problem solving skills
- Strong attention to detail
- Ability to work independently as required
- Strong computer skills; ability to learn and become proficient with appropriate software
- Ability to multitask and prioritize competing demands/work load
- Demonstrated flexibility and adaptability
- Benefits
- Fully remote in the US. Relocation assistance is NOT provided
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, which includes a drug screening
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