- Person is responsible for the overall assessment of compliance, quality control and/or standards defined for the execution of clinical trial(s); included managing CAPA, supporting process improvement initiatives and preparing/analyzing metrics. Will matrix manage with assigned therapeutic area or functional partners to ensure proper documentation of Company procedures, implementation of process changes, ensure compliance and/or execution on timelines and quality deliverables.
- Is aware of both internal and external business environments, assesses impact on the processes for clinical study execution and assists in making modification as necessary.
- Develops initial interpretation of relevant regulations and guidelines initiative to resolve problems and mitigate risk.
location: North Chicago, Illinois
job type: Contract
salary: $25.00 - 30.91 per hour
work hours: 9 to 5
- Responsible for compliance with applicable Corporate and Divisional policies and procedures
- Provides management of clinical compliance, quality and standards projects within Clinical Operations; prepares key performance indicators
- Provides input on new/updates to SOPs, guidelines, work instructions as well as make initial gap assessment of impact of new regulations.
- Effectively communicates project/compliance concerns and actively identifies issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions of solutions to manage the issues.
- GCP exception management in partnership with the business:
- Potential nonconformity
- Planned deviations
- Issue Escalations for potential significant non-compliance
- Inspection support
- Provide consultation on ad-hoc compliance questions
- Bachelor's degree (or equivalent ) is required, typical in nursing or scientific field.
- An Associate's degree/R.N. with relevant experience is acceptable
- Must have 6+ years of Pharma-related/clinical research related experience; 2+ years of experience preferably with clinical research, regulatory, compliance and/or quality control
- Must have demonstrated a high level of core and technical competencies through management of various aspect of clinical trials (e.g., audits, study oversight, SOP development, quality assessments)
- Possesses good communication skills, demonstrated leadership abilities and problem solving skills
- Demonstration of successful coaching/mentoring in a matrix environment
- Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics, and Compliance)
- Preferred global exposure from study initiation through study completion in multiple phases of studies (Phases 1-3, 4).
skills: SOP, Phase I, Phase II, Phase iii, Phase iv, CAPA
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.