Senior Clinical Trial Associate
Who We Are:
MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
What You’ll Do:
The Senior Clinical Trial Associate (Sr. CTA) is required to help support Clinical Operations and project teams. The position offers much responsibility and the opportunity to be involved in all phases of the clinical project. The position requires adaptability and the capacity to ‘own’ tasks, problem solve and to see activities through to their end.
- Interact directly with Clinical (e.g., CRAs, trial managers), site staff, vendors (U.S. and worldwide, as necessary), to provide support in project-specific tasks and the overall management of clinical trials
- Directly support under the guidance of Operational Leaders, Clinical Leaders, and Clinical Trial Managers. Specific responsibilities include:
- Maintain and manage requests for access to and deactivation of study systems users.
- Coordinates materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetings, including requests for materials from external consultants, suppliers, etc.
- Distribute safety alerts and relevant documents, if required
- Maintain and update study team and vendor contact information
- Assist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates
- May participate in reviewing, formatting and finalizing study-related templates, plans and manuals
- Assist with maintaining clinical trial insurance
- Assist with questions, issues or requests from the Clinical Research Organization (CRO)/study team and route to the appropriate individual within the organization for resolution
- May participate in clinical data review, as required
- Responsible for the completeness of documents managed in the Trial Master Files (TMF); performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs and ICH GCP Guidelines
- Route, track and file Clinical documents. May conduct initial/ongoing review of site Clinical regulatory documentation to confirm completeness/track dates and distribute to appropriate team members for review
- Develop and maintain study-related trackers that will support Clinical Operations and individual studies. May analyze or update data associated with the trackers
- Other duties as assigned to support Study Team Leads and Operational Team Leads
- Bachelor’s degree in a relevant subject area is highly recommended or a combination of education and applicable job experience may be considered. (2+ years in the biotech /pharmaceutical industry /clinical trial management area)
- Competency of the drug development process with knowledge of ICH-GCP is a plus
- Strong interpersonal, organizational and planning skills along with excellent verbal and written communication skills
- Proactive and self-starter with the ability to take responsibility for tasks and execute seamlessly. Be able to identify areas for efficiency across studies in the spaces that the position is responsible for.
- Ability to travel up to 35%