i-Pharm Consulting
4 months ago
Clinical Research Associate II
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Company information
- Company
- i-Pharm Consulting
- Location
- Australia, United States
- Posted
- 4 months ago
Job description
Clinical Research Associate II (CRA II) – Global CRO (with a smaller ANZ Team)Australia - remote
Job Summary:
We are seeking a highly motivated and experienced Clinical Research Associate II to join our team in Australia. As a CRA II, you will be responsible for conducting clinical trials at investigator sites, ensuring compliance with Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, and relevant regulatory requirements.
Responsibilities:
- Conduct site initiation visits, monitor visits, and close-out visits to ensure compliance with GCP and ICH guidelines
- Review and approve study-related documents, including informed consent forms, case report forms, and clinical trial protocols
- Ensure accurate and timely data collection, management, and reporting
- Collaborate with investigators, research coordinators, and other stakeholders to resolve issues and address concerns
- Maintain accurate records of site visits, communications, and other activities
Requirements:
- Bachelor's degree in a life science or related field (or equivalent experience)
- At least 2 years of experience as a Clinical Research Associate (CRA) or similar role
- Strong understanding of GCP, ICH guidelines, and relevant regulatory requirements
- Excellent communication, interpersonal, and problem-solving skills
- Ability to work independently and as part of a team
What We Offer:
- Competitive salary and benefits package
- Opportunity to work on diverse clinical trials with global pharmaceutical companies
- Collaborative and dynamic work environment
- Professional development opportunities and training programs
How to Apply:
Please submit your application, including your resume and cover letter, to [insert contact information]. We look forward to hearing from you!
Job Summary:
We are seeking a highly motivated and experienced Clinical Research Associate II to join our team in Australia. As a CRA II, you will be responsible for conducting clinical trials at investigator sites, ensuring compliance with Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, and relevant regulatory requirements.
Responsibilities:
- Conduct site initiation visits, monitor visits, and close-out visits to ensure compliance with GCP and ICH guidelines
- Review and approve study-related documents, including informed consent forms, case report forms, and clinical trial protocols
- Ensure accurate and timely data collection, management, and reporting
- Collaborate with investigators, research coordinators, and other stakeholders to resolve issues and address concerns
- Maintain accurate records of site visits, communications, and other activities
Requirements:
- Bachelor's degree in a life science or related field (or equivalent experience)
- At least 2 years of experience as a Clinical Research Associate (CRA) or similar role
- Strong understanding of GCP, ICH guidelines, and relevant regulatory requirements
- Excellent communication, interpersonal, and problem-solving skills
- Ability to work independently and as part of a team
What We Offer:
- Competitive salary and benefits package
- Opportunity to work on diverse clinical trials with global pharmaceutical companies
- Collaborative and dynamic work environment
- Professional development opportunities and training programs
How to Apply:
Please submit your application, including your resume and cover letter, to [insert contact information]. We look forward to hearing from you!
Required skills
- remote
- management
- reporting
- gcp
- australia
- clinical research associate
- ich
- regulatory requirements
- data collection
- equivalent experience
- related field
- life science
- informed consent forms
- good clinical practice
- case report forms
- investigators
- clinical trial protocols
- site initiation visits
- international conference on harmonisation
- close-out visits
- cra ii
- global cro
- anz team
- monitor visits
- study-related documents
- research coordinators
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