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Freelance CRA, Dermatology/Rheumatology
Innovaderm Research Inc.. Monitor the progress of clinical studies at investigative sites or remotely .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial monitoring, ensuring compliance with ICH-GCP standards and regulatory requirements, while effectively managing relationships with investigators and site staff. Proficient in data verification and documentation, with strong problem-solving and communication skills.
Highest-signal resume keywords
Clinical Trial MonitoringICH/GCP StandardsSource Data VerificationOn-Site Monitoring ExperienceStrong Communication Skills
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 ResearchData CollectionRegulatory Document CollectionSite QualificationMonitoring Plan ExecutionPatient Recruitment StrategiesProblem-SolvingAttention to DetailJudgementExperience in Dermatology
Soft Skills
Verbal CommunicationWritten CommunicationAbility to PrioritizeWork Under PressureRelationship Building
Tools & Technologies
Microsoft OfficeWordExcelPowerPoint
Industry Keywords
BiotechnologyPharmaceuticalCROClinical TrialsInvestigators' Meetings
About the role
Key responsibilities & impact- Monitor the progress of clinical studies at investigative sites or remotely
- Ensure clinical trials are conducted, recorded, and reported according to the protocol, SOPs, ICH-GCP, and applicable regulatory requirements
- Conduct site qualification, initiation, monitoring, and close-out visits according to the monitoring plan and applicable guidelines
- Participate in investigators’ meetings
- Prepare site visit reports and follow-up letters to investigators
- Build productive relationships with investigators and site staff to achieve study objectives and patient recruitment targets
- Perform source data verification
- Ensure on-site study drug storage, dispensing, and accountability are adequate
- Ensure data collection and regulatory document collection are adequate
- Take on other responsibilities when appropriately experienced, qualified, and/or trained
Requirements
What you’ll need- Contractual/Freelance CRA with experience in dermatology and/or rheumatology
- B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
- 3 years of experience conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or CRO industry
- At least 1 year of experience in dermatology
- Good knowledge of ICH/GCP standards and applicable regulatory requirements
- Strong verbal and written communication skills in English
- Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines
- Excellent judgement and problem-solving skills
- Willingness to travel to research sites approximately 65% of the time
- Excellent knowledge of Microsoft Office, including Word, Excel, and PowerPoint
- Must be legally able to work in Australia
Benefits
Comp & perks- Stimulating work environment
- Attractive advancement opportunities
- Recruitment and selection accommodations for applicants with disabilities, upon request