FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research monitoring, including risk-based monitoring and compliance with ICH/GCP Guidelines. Possesses strong communication and organizational skills to effectively manage site relationships and support junior personnel.
Highest-signal resume keywords
Clinical Research MonitoringRisk-Based MonitoringICH/GCP GuidelinesSite ManagementRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementSite EvaluationData SubmissionSafety-Event ReportingMonitoring Plans
Soft Skills
Advanced CommunicationCross-Functional CollaborationPlanning and OrganizationInterpersonal SkillsCritical Thinking
Tools & Technologies
Site Engagement ToolsMonitoring Technology
Industry Keywords
Immunology TherapyInvestigational Drug TrialsPatient JourneyRegulatory Inspection ReadinessClinical Landscape
About the role
Key responsibilities & impact- Advance AbbVie's clinical research pipeline in the immunology therapy area
- Partner with study teams, internal R&D stakeholders, investigators and site staff
- Serve as the primary sponsor point of contact for the investigative site
- Provide contextual information on clinical trials and connect stakeholders with investigative sites
- Align, train and motivate site staff and principal investigators on trial goals, protocol and patient treatment principles
- Support, guide and mentor junior personnel on site management activities
- Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring
- Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs and quality standards
- Customize site engagement strategies and use site engagement tools to track progress and measure impact
- Support recruitment and retention techniques and plans based on the patient disease journey
- Develop knowledge of the therapeutic area, asset, clinical landscape and patient journey
- Mentor and train less experienced CRAs and support onboarding of junior CRAs
- Participate in or lead global and local task forces and initiatives
- Conduct continuous risk assessment in collaboration with the Central Monitoring team
- Identify and resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate and recommend potential investigators and sites
- Ensure quality and timely submission of site data and safety-event reporting
- Maintain audit and regulatory inspection readiness at assigned sites
- Manage investigator payments according to executed contract obligations, as applicable
Requirements
What you’ll need- Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
- Minimum of 3 years of clinically related experience
- 2 years preferable in independent clinical research monitoring of investigational drug or device trials
- Familiarity with risk-based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate therapeutic area indications and scientific concepts related to clinical trials
- Superior knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
- Advanced communication and superior cross-functional collaboration skills
- Superior planning and organizational skills
- Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Ability to leverage technology, tools and resources to provide customer-centric support
- Superior interpersonal skills, including written, verbal, active listening and presentation skills
- Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation and training
- Ability to independently use functional expertise, critical thinking and good judgment to address clinical site issues
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated and focused on delivering timely and quality outcomes in a fast-paced environment
Benefits
Comp & perks- Employees can work remotely
- Equal opportunity employer
- AbbVie is committed to operating with integrity, driving innovation, transforming lives and serving the community
