Senior Clinical Research Associate
ResearchEd
full-time
Posted on:
Location Type: Remote
Location: Australia
Visit company websiteExplore more
Job Level
Tech Stack
About the role
- Monitor clinical trials according to monitoring plans to achieve project goals
- Conduct or assist with site evaluations, study initiations, routine monitoring and site close-outs
- Work with the study start up team and site staff to obtain regulatory approval of study specific documents
- Perform data review activities, collaborate with data management to identify trends and implement corrective action to enhance data quality
- Ensure compliance with appropriate regulations and guidelines throughout the trial
- Participate in project audit/inspection preparation and conduct
Requirements
- University/college degree in life sciences preferred (or the equivalent of 5-6 years industry experience)
- Minimum of 5 years CRA direct monitoring experience with a sponsor company or CRO
- Strong knowledge of Australian clinical trial regulations and ICH GCP guidelines
- Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs
- Proficient with Microsoft Office Suite
- Ability to travel up to 70% as needed
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial monitoringdata reviewregulatory approvaldata managementcorrective actionmedical terminologyprotocol knowledgeregulatory requirementsSOP knowledgemonitoring plans
Soft skills
collaborationcommunicationorganizational skillsattention to detailproblem-solving