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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research monitoring, compliance with ICH/GCP Guidelines, and effective site engagement strategies. Possesses strong interpersonal and organizational skills to foster collaboration and ensure quality outcomes in clinical trials.
Highest-signal resume keywords
Clinical Research MonitoringICH/GCP Guidelines ComplianceSite Engagement StrategiesCross-Functional CollaborationRisk-Based Monitoring
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 Research ExperienceInvestigational Drug TrialsPatient Recruitment TechniquesSite EvaluationMonitoring Plans
Soft Skills
Interpersonal SkillsOrganizational SkillsCritical ThinkingPresentation SkillsActive Listening
Tools & Technologies
CRM ToolsMonitoring Technology
Industry Keywords
Clinical TrialsRegulatory ComplianceTherapeutic Area KnowledgePatient JourneyAudit Readiness
About the role
Key responsibilities & impact- Advance AbbVie's clinical research pipeline by striving for excellence in clinical research
- Partner with investigators and site staff to support meaningful and effective clinical-trial engagements
- Serve as the primary point of contact for investigative sites
- Provide contextual information on clinical trials and connect stakeholders with investigative sites
- Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient-treatment principles
- Conduct site evaluation, site training, routine monitoring, and site-closure monitoring
- Ensure compliance with protocols, monitoring plans, applicable regulations, GCPs, ICH Guidelines, SOPs, and quality standards
- Develop and customize site-engagement strategies for assigned studies
- Gather local and site insights and use CRM tools to report, track, and measure strategy impact
- Evaluate and ensure effective patient recruitment and retention techniques based on the patient disease journey
- Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support recruitment and protocol compliance
- Mentor and train less experienced CRAs and provide development input
- Participate in global or local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team to identify study-performance or patient-safety issues
- Resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate, and recommend investigators and clinical sites
- Ensure quality and timely submission of site data, including safety-event reporting and follow-up
- 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 (Medical, Scientific, Nursing) preferred
- Minimum of 1 year of clinically related experience
- At least 6 months of clinical research monitoring experience involving investigational drug or device trials
- Familiarity with risk-based monitoring, onsite and offsite monitoring
- Knowledge of therapeutic area indications preferred
- Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Strong cross-functional collaboration skills
- Strong planning and organizational skills
- Ability to work effectively in a dynamic environment with competing projects and deadlines
- Advanced ability to leverage technology, tools, and resources
- Strong interpersonal skills and excellent written, verbal, active listening, and presentation skills
- Ability to establish and leverage site relationships and trusted partnerships
- Ability to apply critical thinking and good judgment to address clinical site issues
- Integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes
Benefits
Comp & perks- Paid time off (vacation, holidays, sick)
- Medical, dental, and vision insurance
- 401(k)
- Short-term incentive programs
- Equal opportunity employer
- Reasonable accommodations for applicants
- Veterans/Disabled hiring commitment
