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.
Senior Clinical Research Associate
Alira Health. Conduct site monitoring responsibilities for clinical trials independently .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial monitoring, including oversight of CRA teams, compliance with ICH GCP and FDA regulations, and effective management of study budgets and timelines. Proficient in maintaining strong relationships with sponsors and site teams while ensuring data integrity and quality control.
Highest-signal resume keywords
Clinical Monitoring ExperienceOncology ExpertiseFluency in Dutch/Flemish and EnglishKnowledge of ICH GCP and Local RegulationsBachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy
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 ManagementData Integrity VerificationBudget ManagementSource Document ReviewQuality Control of eTMF/TMFAdverse Event ReportingProblem-Solving StrategiesMonitoring Plan DevelopmentRegulatory Binder ReviewClinical Research Knowledge
Soft Skills
Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsLeadership SkillsCustomer Service Orientation
Tools & Technologies
Clinical Trial Management SystemsClinical Trial DatabasesElectronic Data Capture
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryCRO IndustryGCP ComplianceEthical Requirements
About the role
Key responsibilities & impact- Conduct site monitoring responsibilities for clinical trials independently
- Provide oversight, leadership, and guidance in the management and execution of clinical trials
- Guide, oversee, and provide feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
- Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed
- Ensure appropriate and timely investigator site visits
- Coordinate cross-functional departments to resolve clinical trial monitoring issues
- Assist with study-specific Monitoring Plans and training presentations
- Assist with ethics-document collection and site contract negotiation
- Provide monthly billing information to finance
- Manage study budgets and act as sponsor referent for stand-alone projects
- Perform qualification, initiation, interim, and close-out visits remotely and onsite
- Prepare accurate monitoring visit reports covering site problems, resolutions, protocol deviations, study progress, and enrollment
- Conduct source document review and verification to ensure CRF data integrity
- Perform quality control and verification of eTMF/TMF documents
- Conduct investigational product accountability
- Review site regulatory binders
- Maintain regular site contact to ensure protocol/GCP compliance and assess patient accrual
- Ensure compliance with ICH GCP, FDA regulations, and company/Sponsor SOPs
- Participate in internal, client/sponsor, scientific, and other meetings
- Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
- Resolve discrepant-data queries with in-house CRAs/CTC and data management
- Identify site issues and develop problem-solving strategies
- Conduct audit preparation at study sites
- Support CRA collaboration and consistency
- Assist with CRA new-hire training and onboarding
- Mentor CRAs
- Collaborate on development and maintenance of the Clinical Trial Management System (CTMS)
- Manage conflicting priorities and deliver on commitments
- Perform additional assigned duties
Requirements
What you’ll need- Minimum 3 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry
- Ability to autonomously manage monitoring activities
- Experience in Oncology
- Availability to travel in Netherland and Belgium
- Fluency in Dutch/Flemish and English
- Strong command of the local language, both written and verbal, in the country where monitoring activities are performed
- Excellent communication and interpersonal skills with customer service orientation
- Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture
- Knowledge of clinical research, ICH GCP and local regulations
- Knowledge of Regulatory and Ethical requirements
- Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
- Graduation in a scientific health field
- Adequate English
- Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy
- Ability to travel
- Quality focused; careful, thorough, and detail-oriented
- Strong organizational skills and ability to multi-task and work effectively in a fast-paced environment
- Ability to manage priorities, organize time and solve problems
- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- Ability to manage stress
- Professional, trustworthy and disciplined
- Ability to problem-solve unstructured or ambiguous challenges
- Self-starter who thrives in a collaborative, yet less structured team environment
Benefits
Comp & perks- Remote work arrangement
- Part-time work schedule
- Contingency Workforce contract arrangement