Quality Assurance - Clinical Research

ViTalent is a premier professional services organization serving the Life Sciences, Clinical Research and Healthcare industries. We have an exciting opportunity to support clinical site operations as a Quality Assurance Specialist. This is a contract position with the potential for extensions or permanent placement.

Must have at least 4 years of clinical research experience in pharmaceutical or biotech field.

Key Accountabilities

• Represent GCP Compliance in meetings as needed.
• Provides near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes.
• Performs proactive as well as routine evaluation of clinical trial processes to determine adherence to process and procedural documentation through documentation review and active engagement with study team functional representatives
• Performs other duties as assigned.
• Ensure compliance with Sponsor Learning Curricula, corporate and/or GXP requirements.
• Helps develop and maintain KPIs, metrics and dashboards to track process quality and compliance

CORE COMPETENCIES

Good understanding of clinical trial processes related to sponsor activities, including but not limited to sponsor oversight, issue management, site management and clinical monitoring.

PROJECT SPECIFICS

• Domestic/international travel (5-20%) to other Sponsor sites, strategic partners, and therapeutic area events may be required
• Medium complexity projects and/or platforms.
• Moderate supervision required, should be able to function collaboratively with all levels of employees.

Education, Experience, Competencies And Skills

• Effectively resolve conflict in a constructive manner
• Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs.
• Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements
• Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
• BS, MS or equivalent in scientific field
• Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
• Solid knowledge of drug development, clinical trial management and/or GCP compliance processes
• Minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field

If you are qualified and interested, please submit your resume. Thank you.

#CLINICALRESEARCH

#CLINICAL RESEARCH