Clinical Research Associate (US-based, East Coast)
Behavioral Health Market Context
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Job Description
vides site monitoring support for sponsored clinical studies.
• Performs on-site and remote initiation, routine, and closeout visits.
• Prepares site visit reports and provides assistance to site staff in resolving deficiencies.
• Educates and trains site and study staff in management of sponsored studies, including regulatory and ICH/GCP compliance.
• Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
• Develops and demonstrates understanding and application of therapeutic area knowledge to assignments and project-related issues.
• Appropriately resolves issues related to trial monitoring and management with guidance from the Project Manager, Clinical Monitoring.
• Makes independent decisions with some supervision from the Senior Director, Research & Development, or the Project Manager, Research & Development.
• Performs primarily intellectual tasks and exercises discretion and independent judgment.
Qualifications:
• Working knowledge of SOPs along with FDA and ICH/GCP guidelines.
• Good communication, organizational, and writing skills.
• Develops and applies efficient computer tools to carry out job functions.
• Attention to detail; ability to work in a team environment.
• Dependable; assumes responsibility and accepts, supports, and positively facilitates change.
• Ability and availability to communicate with sites in different US time zones.
• Willingness to travel.
• Working knowledge of Microsoft Office suite
• Working knowledge of clinical trials electronic tools (CTMS, eTMF, EDC, IRT).
Education and Experience:
• BS/MS/RN or equivalent in scientific or health care field.
• At least 3 years of pharmaceutical, clinical, or biological research with 2 years of Clinical Research Associate experience in oncology.
• Performs on-site and remote initiation, routine, and closeout visits.
• Prepares site visit reports and provides assistance to site staff in resolving deficiencies.
• Educates and trains site and study staff in management of sponsored studies, including regulatory and ICH/GCP compliance.
• Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
• Develops and demonstrates understanding and application of therapeutic area knowledge to assignments and project-related issues.
• Appropriately resolves issues related to trial monitoring and management with guidance from the Project Manager, Clinical Monitoring.
• Makes independent decisions with some supervision from the Senior Director, Research & Development, or the Project Manager, Research & Development.
• Performs primarily intellectual tasks and exercises discretion and independent judgment.
Qualifications:
• Working knowledge of SOPs along with FDA and ICH/GCP guidelines.
• Good communication, organizational, and writing skills.
• Develops and applies efficient computer tools to carry out job functions.
• Attention to detail; ability to work in a team environment.
• Dependable; assumes responsibility and accepts, supports, and positively facilitates change.
• Ability and availability to communicate with sites in different US time zones.
• Willingness to travel.
• Working knowledge of Microsoft Office suite
• Working knowledge of clinical trials electronic tools (CTMS, eTMF, EDC, IRT).
Education and Experience:
• BS/MS/RN or equivalent in scientific or health care field.
• At least 3 years of pharmaceutical, clinical, or biological research with 2 years of Clinical Research Associate experience in oncology.
Qualifications
- •Working knowledge of SOPs along with FDA and ICH/GCP guidelines
- •Good communication, organizational, and writing skills
- •Develops and applies efficient computer tools to carry out job functions
- •Attention to detail; ability to work in a team environment
- •Dependable; assumes responsibility and accepts, supports, and positively facilitates change
- •Ability and availability to communicate with sites in different US time zones
- •Willingness to travel
- •Working knowledge of Microsoft Office suite
- •Working knowledge of clinical trials electronic tools (CTMS, eTMF, EDC, IRT)
- •BS/MS/RN or equivalent in scientific or health care field
- •At least 3 years of pharmaceutical, clinical, or biological research with 2 years of Clinical Research Associate experience in oncology
Benefits
Responsibilities
- •Reports to: Project Manager, Research & Development
- •Summary: Provide clinical trial-related monitoring activities including remote and on-site visits to the US sites participating in investigational studies
- •Provides site monitoring support for sponsored clinical studies
- •Performs on-site and remote initiation, routine, and closeout visits
- •Prepares site visit reports and provides assistance to site staff in resolving deficiencies
- •Educates and trains site and study staff in management of sponsored studies, including regulatory and ICH/GCP compliance
- •Collects and processes regulatory documentation for investigational studies in compliance with required guidelines
- •Develops and demonstrates understanding and application of therapeutic area knowledge to assignments and project-related issues
- •Appropriately resolves issues related to trial monitoring and management with guidance from the Project Manager, Clinical Monitoring
- •Makes independent decisions with some supervision from the Senior Director, Research & Development, or the Project Manager, Research & Development
- •Performs primarily intellectual tasks and exercises discretion and independent judgment
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