Clinical Research Associate, Contractor
Essential Skills Needed for Assignment:
• Assist in the management of global Ph II and III clinical trial activities to ensure compliance with the study protocol and overall clinical study objectives; particular emphasis on routine monitoring trip report review and protocol deviation tracking
• Manage the clinical trial activities performed by the service-specific vendors, with emphasis on biological sample management
• Co-monitor investigational study sites and assist with the management of the CRO to verify that study conduct is in compliance with the protocol, regulations and company SOPs
• Manage the coordination of activities between vendors; ensuring deliverables are achieved in accordance with the study timelines
• Manage and track the progress of the vendor activities, reporting status updates and alerting the study team of potential delays
• Position may require approximately 10% domestic travel
Education and Experience:
• Position requires a minimum of a Bachelor’s degree, preferably in a health/medical related field or life sciences
• Minimum of 3 years clinical trial experience in the pharmaceutical or biotechnology industry
Technical/Non-Technical Skills:
• This individual should possess a thorough understanding of clinical drug development and be proficient in GCP, ICH and the regulatory requirements for clinical trials
• Must be able to manage and coordinate several vendors
• Must have experience managing service-specific vendors
• Strong organizational, communication and interpersonal skills
• Ability to multi-task is essential
Essential Skills Needed for Assignment:
• Assist in the management of global Ph II and III clinical trial activities to ensure compliance with the study protocol and overall clinical study objectives; particular emphasis on routine monitoring trip report review and protocol deviation tracking
• Manage the clinical trial activities performed by the service-specific vendors, with emphasis on biological sample management
• Co-monitor investigational study sites and assist with the management of the CRO to verify that study conduct is in compliance with the protocol, regulations and company SOPs
• Manage the coordination of activities between vendors; ensuring deliverables are achieved in accordance with the study timelines
• Manage and track the progress of the vendor activities, reporting status updates and alerting the study team of potential delays
• Position may require approximately 10% domestic travel
Education and Experience:
• Position requires a minimum of a Bachelor’s degree, preferably in a health/medical related field or life sciences
• Minimum of 3 years clinical trial experience in the pharmaceutical or biotechnology industry
Technical/Non-Technical Skills:
• This individual should possess a thorough understanding of clinical drug development and be proficient in GCP, ICH and the regulatory requirements for clinical trials
• Must be able to manage and coordinate several vendors
• Must have experience managing service-specific vendors
• Strong organizational, communication and interpersonal skills
• Ability to multi-task is essential