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 extensive clinical monitoring experience, with a strong focus on oncology and adherence to regulatory requirements. Capable of managing study budgets, conducting site visits, and providing leadership to CRA teams while ensuring quality and compliance in clinical trials.
Highest-signal resume keywords
Clinical Monitoring ExperienceOncology ExperienceKnowledge of ICH GCPClinical Trial Management SystemsBachelor's Degree in Life Sciences
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site MonitoringProtocol AdherenceData Integrity VerificationQuality Control of eTMF/TMFBudget ManagementProblem-Solving StrategiesAdverse Event ReportingNegotiation SkillsTraining and MentoringStudy Site Audits
Soft Skills
Strong Organizational SkillsExcellent Communication SkillsInterpersonal SkillsAbility to Multi-TaskTrustworthy and Disciplined
Tools & Technologies
Clinical Trial Management SystemsClinical Trial DatabasesElectronic Data Capture
Industry Keywords
Pharmaceutical IndustryBiotechnologyCRO IndustryRegulatory RequirementsEthical Requirements
About the role
Key responsibilities & impact- Conduct site monitoring responsibilities for clinical trials independently
- Provide oversight, leadership, and guidance to CRA teams
- Ensure adherence to project scope, SOPs, timelines, budgets, protocol, GCP, and regulatory requirements
- Review monitoring visit reports and conduct co-monitoring and evaluation visits
- Ensure timely investigator site visits
- Coordinate cross-functional issue resolution for clinical trial monitoring
- Assist with Monitoring Plans, training presentations, ethics documents, 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 issues, resolutions, protocol deviations, study progress, and enrollment
- Verify source documents and CRF data integrity
- Perform quality control of eTMF/TMF documents and investigational product accountability
- Review site regulatory binders
- Maintain site contact, assess patient accrual, and respond to sponsor requests
- Facilitate adverse event reporting and SAE reconciliation
- Resolve discrepant data queries with in-house CRAs, CTC, and data management
- Identify site issues and develop problem-solving strategies
- Prepare study sites for audits
- Mentor and train CRAs, including new-hire onboarding
- Collaborate on CTMS development and maintenance
- Manage conflicting priorities and 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
- Oncology experience
- Availability to travel in Belgium and Netherlands
- Quality focused; careful, thorough, and detail-oriented
- Strong organizational skills and ability to multi-task 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 travel and manage stress
- Professional, trustworthy, and disciplined
- Ability to problem-solve unstructured or ambiguous challenges
- Strong command of the local language, written and verbal, in the country where monitoring activities are performed
- Excellent communication and interpersonal skills with customer service orientation
- Good computer skills, including 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's degree in Biology, Biotechnology, Life Sciences, Pharmacy, or related scientific health field
Benefits
Comp & perks- Remote work
- Regular employment contract