- The CTL is responsible for the leadership of CRAs on their assigned study(s), driving the team to ensure study deliverables are met with quality and efficiency from study feasibility and startup through close out
- Contributes to the Clinical Monitoring Plan, monitoring tools, visit report annotations, and CRA training materials
- Responsible for ensuring study training compliance is maintained
- Ensure proper training for study sites on required imaging procedures and other diagnostic tools
- Reviews monitoring visits, tracks scheduling, reviews reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed
- Responsible for reviewing clinical data (e.g. electronic case report forms, central laboratory data, risk based monitoring outputs, etc...) to ensure the CRAs are informed and managing their site's data with quality and integrity
- Ensures clinical, imaging, and other diagnostic data from sites and vendors (e.g. labs are of quality and delivered in accordance with established data entry and cleaning timelines and deliverables. Follow up on queries as needed.
- Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times
- Conducts regular meetings with CRO to disseminate timely and relevant updates and best practices for consistency and efficiency
- Conducts co-monitoring visits, oversight visits, audits, and other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs
- Works with the study team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery
- Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion
- Excellent critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Proactively identifies and communicates site management and monitoring issues to key stakeholders
- Bachelor's or equivalent degree required, preferably in life sciences, medicine or related discipline, or equivalent experience
- Minimum of 2 years managing CRAs and at least 3 years of experience in clinical site monitoring
- Ability to travel domestically % on average
- Excellent writing, verbal communication, presentation, and interpersonal skills
- Able to take initiative to improve work processes, develop innovative methodologies and approaches to enhance monitoring activities for quality and efficiency
- Expert knowledge of ICH/GCP, applicable standards, and FDA regulations for clinical trials
- Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology
- Detail oriented with excellent organizational skills
- Flexibility with changing priorities
- Experience in cell therapy trials
- Experience partnering with CROs
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Clinical Trial Lead - South San Francisco, United States - Neurona Therapeutics
Description
CLINICAL TRIAL LEAD - U.S. BASED REMOTE OPPORTUNITY POSITIONNeurona Therapeutics is an early-stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for neurological diseases. Our ideal candidate is a self-motivated individual who has a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and take part in building an exciting, science-driven company.
The Clinical Trial Lead (CTL) provides operational expertise and leadership to ensure the effective and efficient delivery of clinical site monitoring on our clinical trials. The CTL is the key representative for clinical monitoring on the Study Team. They provide leadership and direction to our CRO throughout the lifecycle of a study. The CTL assesses clinical trial site performance, adequacy of monitoring activities, reviews monitoring visit reports and metrics, and proactively identifies and communicates site management and monitoring issues and risks to the Study Team. The CTL ensures the monitoring activities of their assigned study(s) are in accordance with Neurona Therapeutics' policies and procedures, ICH/GCP, and local regulations. The CTL will report directly to the Associate Director, Clinical Operations and Development.
Responsibilities:
Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
