Senior Clinical Research Associate - Oncology
Behavioral Health Market Context
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Job Description
ons such as ICH-GCP, and local requirements.
Key Responsibilities:
• Site Management:
• Assist in selecting potential investigators.
• Manage the study start-up process, including document preparation for regulatory submissions.
• Provide training and ongoing support to investigators and site personnel, ensuring adherence to Risk-Based Quality Management principles.
• Verify training completion for site staff and maintain inspection readiness.
• Actively engage in Local Study Team meetings and National Investigator meetings.
• Monitor study site performance and share updates on patient recruitment.
• Proactively address study-related issues and escalate as necessary.
• Ensure timely data entry and updates within the CTMS and manage study supplies.
• Conduct regular monitoring visits and Source Data Verification in accordance with the Monitoring Plan.
• Oversee timely resolution of data queries and manage study documentation effectively.
• Compliance and Quality Assurance:
• Ensure compliance with ethical standards, company policies, and applicable regulations.
• Prepare for audits and inspections in collaboration with study leadership.
• Support the maintenance of inspection-ready documentation throughout the study lifecycle.
• Facilitate the collection and organization of essential documents for eTMF submission.
• Provide feedback on site performance and competitive landscape.
• Collaboration and Communication:
• Work closely with Medical Science Liaisons as directed.
• Maintain positive relationships with site staff and leadership.
Required Skills:
• Strong attention to detail and organizational abilities.
• Excellent verbal and written communication skills in English and local languages.
• Effective collaboration and negotiation skills.
Experience and Education:
• Bachelor's degree in a relevant life science discipline.
• Extensive knowledge of ICH-GCP guidelines and local regulations.
• Familiarity with the drug development process and clinical study management.
Additional Information:
• Willingness to travel as required.
• Valid driving license as per country requirements.
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Key Responsibilities:
• Site Management:
• Assist in selecting potential investigators.
• Manage the study start-up process, including document preparation for regulatory submissions.
• Provide training and ongoing support to investigators and site personnel, ensuring adherence to Risk-Based Quality Management principles.
• Verify training completion for site staff and maintain inspection readiness.
• Actively engage in Local Study Team meetings and National Investigator meetings.
• Monitor study site performance and share updates on patient recruitment.
• Proactively address study-related issues and escalate as necessary.
• Ensure timely data entry and updates within the CTMS and manage study supplies.
• Conduct regular monitoring visits and Source Data Verification in accordance with the Monitoring Plan.
• Oversee timely resolution of data queries and manage study documentation effectively.
• Compliance and Quality Assurance:
• Ensure compliance with ethical standards, company policies, and applicable regulations.
• Prepare for audits and inspections in collaboration with study leadership.
• Support the maintenance of inspection-ready documentation throughout the study lifecycle.
• Facilitate the collection and organization of essential documents for eTMF submission.
• Provide feedback on site performance and competitive landscape.
• Collaboration and Communication:
• Work closely with Medical Science Liaisons as directed.
• Maintain positive relationships with site staff and leadership.
Required Skills:
• Strong attention to detail and organizational abilities.
• Excellent verbal and written communication skills in English and local languages.
• Effective collaboration and negotiation skills.
Experience and Education:
• Bachelor's degree in a relevant life science discipline.
• Extensive knowledge of ICH-GCP guidelines and local regulations.
• Familiarity with the drug development process and clinical study management.
Additional Information:
• Willingness to travel as required.
• Valid driving license as per country requirements.
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Qualifications
- •Strong attention to detail and organizational abilities
- •Excellent verbal and written communication skills in English and local languages
- •Effective collaboration and negotiation skills
- •Bachelor's degree in a relevant life science discipline
- •Extensive knowledge of ICH-GCP guidelines and local regulations
- •Familiarity with the drug development process and clinical study management
- •Willingness to travel as required
- •Valid driving license as per country requirements
Benefits
Responsibilities
- •The Senior Clinical Research Associate (Sr CRA) is pivotal in overseeing and delivering studies at assigned sites, working closely with the local study team to meet study goals efficiently
- •As the primary point of contact for study sites, the Sr CRA is responsible for the entire lifecycle of site management, ensuring compliance with Client Procedural Documents, international regulations such as ICH-GCP, and local requirements
- •Site Management:
- •Assist in selecting potential investigators
- •Manage the study start-up process, including document preparation for regulatory submissions
- •Provide training and ongoing support to investigators and site personnel, ensuring adherence to Risk-Based Quality Management principles
- •Verify training completion for site staff and maintain inspection readiness
- •Actively engage in Local Study Team meetings and National Investigator meetings
- •Monitor study site performance and share updates on patient recruitment
- •Proactively address study-related issues and escalate as necessary
- •Ensure timely data entry and updates within the CTMS and manage study supplies
- •Conduct regular monitoring visits and Source Data Verification in accordance with the Monitoring Plan
- •Oversee timely resolution of data queries and manage study documentation effectively
- •Compliance and Quality Assurance:
- •Ensure compliance with ethical standards, company policies, and applicable regulations
- •Prepare for audits and inspections in collaboration with study leadership
- •Support the maintenance of inspection-ready documentation throughout the study lifecycle
- •Facilitate the collection and organization of essential documents for eTMF submission
- •Provide feedback on site performance and competitive landscape
- •Collaboration and Communication:
- •Work closely with Medical Science Liaisons as directed
- •Maintain positive relationships with site staff and leadership
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