- Conduct evidence based feasibility to establish viability of study at potential sites
- Support study team during the feasibility and site ID process to collect relevant data
- Develop appropriate site selection and patient retention plans, including the site selection recruitment process
- Document and track site feasibility progress
- Ensure Pre-Study Visits occur per established timelines
- Review Pre-Study Visit Reports
- Support facilitation of the negotiation of site contracts and budgets
- Support facilitation of the preparation of documents for ethics committee/other committee submissions (e.g. informed consent form, patient facing materials)
- Answer site and CRO questions in preparation for submission to ethics/other committee submission
- Facilitating or scheduling site trainings required per study protocol
- Development of study start up materials (study plans and templates)
- Ensure proper training for study sites on required imaging / diagnostic procedures and other diagnostic tools
- Manage receipt of imaging results in required format
- Generation of queries related to imaging
- Central lab management
- Ensure timely, consistent and quality set up and maintenance of TMF requirements and processes
- Oversee audits related to TMF activities and processes
- Management of timely resolution to TMF findings
- Review and report metrics established for TMF reviews
- Track TMF deliverables
- Proactively identifies and communicates site performance and monitoring issues to key stakeholders and implements action plans in conjunction with the study team
- Bachelor's degree in live sciences or a licensed healthcare professional such as RN or equivalent experience
- Minimum of 2 years industry experience in related role (site management, study coordinator, in-house CRA)
- Excellent writing, verbal communication, presentation, and interpersonal skills
- Able to work within a team environment and take initiative to improve work processes, develop innovative methodologies and approaches to enhance study activities for quality and efficiency
- Good understanding of ICH/GCP, applicable standards, and FDA regulations for clinical trials
- Detail oriented with excellent planning and organizational skills
- Flexibility with changing priorities
- Good computer skills (MS Office, Google mail, docs and sheets, BOX, Sharepoint, EDC, Veeva, other similar systems)
- Ability to travel up to 10% nationwide
- Experience in cell therapy trials
- Clinical trial support experience partnering with CROs
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In-House Clinical Research Associate - South San Francisco, United States - Neurona Therapeutics
Description
In House Clinical Research Associate (IHCRA) - REMOTE 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 inhouse clinical research associate (IHCRA) provides operational support to ensure the effective and efficient delivery
of clinical site monitoring on our clinical trials. The IHCRA works with study team and CRO throughout the lifecycle of a
study. The IHCRA tracks 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 IHCRA verifies the monitoring activities of their assigned study(s) are in accordance with Neurona Therapeutics'
policies and procedures, ICH/GCP, and local regulations. The IHCRA will report directly to the Associate Director, Clinical
Operations and Development.
This job is approved for remote work within the United States.
Responsibilities:
