Senior Clinical Research Associate – CVM/IMID

Worldwide Clinical Trials

. Perform feasibility studies for potential sites .

Posted 9/25/2026full-timeRemote • AustraliaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive understanding of clinical research principles, FDA and EU regulations, and ICH Guidelines while effectively managing site compliance and mentoring Clinical Research Associates. Proficient in developing Clinical Monitoring Plans and conducting training for study team members.

Highest-signal resume keywords

Clinical Research Associate ExperienceClinical Monitoring Plan DevelopmentFDA and EU Regulatory KnowledgeProficiency in Microsoft OfficeSite Management and Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research PrinciplesSite Visit DocumentationSource Document VerificationProtocol Adherence TrainingData Query ResolutionRegulatory Submission DocumentationStudy-Specific Tool DesignTherapeutic Area KnowledgeInvestigator Site File MaintenanceClinical Trial Close-Out

Soft Skills

Excellent Communication SkillsOrganizational SkillsInterpersonal SkillsTime Management SkillsProblem-Solving Skills

Tools & Technologies

IxRS SystemsEDC SystemsMicrosoft Office

Certifications & Qualifications

Medical Doctor (MD)Pharmacist Degree (MSPH, PharmD, PhD)

Industry Keywords

Clinical ResearchFDA RegulationsEU DirectivesICH GuidelinesStandard Operating Procedures

About the role

Key responsibilities & impact

Perform feasibility studies for potential sites
Conduct pre-study, study initiation, interim monitoring, site management, and study close-out visits
Function as Lead CRA for global studies and coordinate CRAs
Develop Clinical Monitoring Plans
Review site visit trip reports and provide feedback
Mentor and guide less experienced CRAs and site staff
Design study-specific tools and templates
Participate in study team, investigator, and bid defense meetings
Create and conduct training for study team members or colleagues
Work with Project Management to evaluate deliverables and study milestones
Compile regulatory and ethical submission documentation
Coordinate shipment and receipt of study materials
Document site visit findings in written reports
Provide input into protocols and CRFs
Assess, monitor, and train site staff on protocol adherence
Review subject safety information and informed consent
Conduct source document verification
Review CRFs in paper or electronic data capture systems and assist with data query resolution
Assist sites with Investigator Site File maintenance
Maintain regular communication with sites
Update site-related documentation for Trial Master File filing
Ensure site compliance with investigational product receipt, accountability, and return or destruction
Conduct accompanied site visits for CRA assessment or training
Complete final site close-out visits and reports
Perform other duties as assigned

Requirements

What you’ll need

Medical Doctor (MD) degree or Pharmacist degree (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc.) and a minimum of three years as a Clinical Research Associate
OR a minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science and a minimum of five years as a Clinical Research Associate
OR two-year college curriculum or equivalent education/training and a minimum of seven years as a Clinical Research Associate
Willingness to travel
Valid current passport
Driving license
Fluent in the local languages of the countries under responsibilities
Proficient in spoken and written English
Extensive understanding of clinical research principles and processes
Thorough understanding of FDA and/or EU Directives and regulations, ICH Guidelines, and local regulatory requirements
Thorough understanding of two to three therapeutic areas
Thorough understanding of standard operating procedures
Proficiency in Microsoft Office
Proficiency with IxRS and EDC systems
Excellent oral and written communication skills
Excellent planning, organizational, interpersonal, time management, initiative, and problem-solving skills

Benefits

Comp & perks

Diverse and inclusive work environment
Supportive and cohesive teams
Accessible leadership
Equal employment opportunities
Employee experience focused workplace