Senior Clinical Research Associate - Oncology
Behavioral Health Market Context
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Job Description
ce with Good Clinical Practices (GCP) as well as the Sponsor's standards.
Key Responsibilities:
• Oversee the conduct of clinical trials, ensuring adherence to the Study Monitoring Plan (SMP), applicable laws, and best practices while achieving project goals and timelines.
• Manage the operational aspects of clinical trial activities, from site activation to database lock, ensuring timely and quality deliverables.
• Act as the primary contact for investigator sites, facilitating effective communication and escalation of issues as needed.
• Collaborate with the Site Care Partner to develop and train site personnel to ensure ongoing protocol compliance and patient safety.
• Attend investigator meetings as required, providing support for site enrollment and recruitment initiatives.
• Conduct comprehensive onsite and remote monitoring, ensuring compliance with SOPs and responding to emerging issues.
• Monitor site adverse events (AEs) and serious adverse events (SAEs), collaborating with the Drug Safety Unit to ensure timely resolution.
• Provide timely submission of required reports and documentation, maintaining all necessary tracking.
• Identify and resolve site-related issues, collaboratively developing corrective actions to prevent recurrence.
• Perform close-out activities in a timely manner and ensure the appropriate oversight of investigational products at the site.
• Assist with database lock processes as necessary.
Qualifications:
• In-depth knowledge of clinical trial methodologies, ICH/GCP guidelines, FDA regulations and local country laws.
• Minimum of 3 years in clinical research site monitoring, ideally with at least 2 years of experience in Oncology.
• Therapeutic expertise in Oncology, Vaccines, Internal Medicine, or Infectious Diseases is preferred.
• Fluency in English and the local language(s) applicable to the site is mandatory.
• Able and willing to travel 60-80% of the time.
• A valid driver’s license and passport are required.
Education:
• Bachelor's degree in life sciences or a professional degree in nursing, pharmacy, or medicine, or an equivalent qualification.
Parexel is proud to be an equal opportunity employer. We encourage applications from all qualified candidates regardless of background.
Key Responsibilities:
• Oversee the conduct of clinical trials, ensuring adherence to the Study Monitoring Plan (SMP), applicable laws, and best practices while achieving project goals and timelines.
• Manage the operational aspects of clinical trial activities, from site activation to database lock, ensuring timely and quality deliverables.
• Act as the primary contact for investigator sites, facilitating effective communication and escalation of issues as needed.
• Collaborate with the Site Care Partner to develop and train site personnel to ensure ongoing protocol compliance and patient safety.
• Attend investigator meetings as required, providing support for site enrollment and recruitment initiatives.
• Conduct comprehensive onsite and remote monitoring, ensuring compliance with SOPs and responding to emerging issues.
• Monitor site adverse events (AEs) and serious adverse events (SAEs), collaborating with the Drug Safety Unit to ensure timely resolution.
• Provide timely submission of required reports and documentation, maintaining all necessary tracking.
• Identify and resolve site-related issues, collaboratively developing corrective actions to prevent recurrence.
• Perform close-out activities in a timely manner and ensure the appropriate oversight of investigational products at the site.
• Assist with database lock processes as necessary.
Qualifications:
• In-depth knowledge of clinical trial methodologies, ICH/GCP guidelines, FDA regulations and local country laws.
• Minimum of 3 years in clinical research site monitoring, ideally with at least 2 years of experience in Oncology.
• Therapeutic expertise in Oncology, Vaccines, Internal Medicine, or Infectious Diseases is preferred.
• Fluency in English and the local language(s) applicable to the site is mandatory.
• Able and willing to travel 60-80% of the time.
• A valid driver’s license and passport are required.
Education:
• Bachelor's degree in life sciences or a professional degree in nursing, pharmacy, or medicine, or an equivalent qualification.
Parexel is proud to be an equal opportunity employer. We encourage applications from all qualified candidates regardless of background.
Qualifications
- •In-depth knowledge of clinical trial methodologies, ICH/GCP guidelines, FDA regulations and local country laws
- •Minimum of 3 years in clinical research site monitoring, ideally with at least 2 years of experience in Oncology
- •Fluency in English and the local language(s) applicable to the site is mandatory
- •Able and willing to travel 60-80% of the time
- •A valid driver’s license and passport are required
- •Bachelor's degree in life sciences or a professional degree in nursing, pharmacy, or medicine, or an equivalent qualification
Benefits
Responsibilities
- •CRA) where you will play a critical role in managing and monitoring clinical trial sites to ensure patient safety and uphold the highest quality standards in clinical research
- •You will collaborate closely with investigator sites and be responsible for managing relationships, resolving protocol-related issues, and ensuring compliance with Good Clinical Practices (GCP) as well as the Sponsor's standards
- •Oversee the conduct of clinical trials, ensuring adherence to the Study Monitoring Plan (SMP), applicable laws, and best practices while achieving project goals and timelines
- •Manage the operational aspects of clinical trial activities, from site activation to database lock, ensuring timely and quality deliverables
- •Act as the primary contact for investigator sites, facilitating effective communication and escalation of issues as needed
- •Collaborate with the Site Care Partner to develop and train site personnel to ensure ongoing protocol compliance and patient safety
- •Attend investigator meetings as required, providing support for site enrollment and recruitment initiatives
- •Conduct comprehensive onsite and remote monitoring, ensuring compliance with SOPs and responding to emerging issues
- •Monitor site adverse events (AEs) and serious adverse events (SAEs), collaborating with the Drug Safety Unit to ensure timely resolution
- •Provide timely submission of required reports and documentation, maintaining all necessary tracking
- •Identify and resolve site-related issues, collaboratively developing corrective actions to prevent recurrence
- •Perform close-out activities in a timely manner and ensure the appropriate oversight of investigational products at the site
- •Assist with database lock processes as necessary
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