Digital Operations, QC Specialist II - CRG
$60,000–$80,000 year
RemoteUnited States
Job Summary
Coordinate the global clinical study configuration QC process, managing study-level quality checks for documentation, communication, risk identification, and SOP compliance. Review study configurations across finance CTMS and eSource to ensure accuracy against protocol requirements, budgets, and site network needs while adhering to regulatory guidelines. Identify, investigate, and resolve technical and configuration-related issues by partnering with study builders to understand build designs before initiating QC activities. Collaborate with stakeholders to resolve configuration questions and communicate study-level quality findings to drive appropriate resolutions. Identify opportunities to strengthen processes and lead technology implementations for continuous quality improvement across the organization.
Required Qualifications
- Bachelor's degree or equivalent relevant formal academic or vocational qualification
- Previous technical QC or technical build experience (comparable to 5 years)
- Experience working with ICH-GCP, FDA, and other applicable regulatory guidelines
- 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
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
- Able to work upright and stationary for typical working hours
- Ability to use and learn standard office equipment and technology with proficiency
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
- May require as-needed travel (0-20%)
Desired Qualifications
- Experience with medical terminology, clinical research protocols, clinical study budgets/contracts, and study documentation
- In-depth knowledge of study configuration processes
- Strong judgment and decision-making skills
- Excellent analytical and problem-solving abilities
- The ability to work independently and adapt to rapidly changing priorities
- Strong organization and time-management skills
- The ability to use software and systems to organize information and produce reports, including the ability to learn and retain knowledge of applications used to develop study configurations for clinical sites
- A continuous-improvement mindset and the ability to identify opportunities to improve efficiency and processes
- Excellent attention to detail and a strong commitment to quality
- Demonstrated project management, communication, and organizational skills
- Strong collaboration skills and a positive, professional approach
- The ability to effectively manage a high-volume workload while meeting deadlines
- Confidence presenting information to management and stakeholders
- The ability to apply professional concepts, company policies, and established procedures to resolve issues and deliver effective solutions
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