Lead Clinical Trial Assistant
San Diego Metro Area, California
Bachelor s degree in a scientific or health care discipline 2+ years experience in clinical trials research
Prior experience working with a Project and Trial Master File in a regulatory environment.
Prior experience managing and maintaining a CTMS for one or more studies.
Experience in working with Finance on tracking Trial, Site and CRO budgets and processing project related invoices.
Thorough understanding of GCP is required
The Lead Clinical Trial Assistant (CTA) in collaboration with the Clinical Trial Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders
Use performance metrics and quality indicators to assist the clinical trial manager in driving study execution
Lead / Participate in monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans
Ensure full compliance (completeness & accuracy) of the required data in study management tools including CTMS, patient enrollment forecasting, etc.
Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
Develop and maintain collaborative relationships with internal and external partners/stakeholders
Collaborate with vendors and other internal stakeholders regarding study specific issues and follow through to resolution
Actively contribute to study meetings including: presentation, subject matter expert, generate, finalize and distribute study team agendas and meeting minutes, etc.
Contribute to development / coordination of study training for study team, investigational sites, and vendors
Assist with the collection of various study documents such as country/site insurance, CSR appendices, etc.
Contribute to ordering and distribution of materials as required
Support the development/coordination of study training materials for study team, investigational sites, and vendors in conjunction with study manager
Manage collection, review and tracking of study documents as necessary
Monitor contents of electronic trial master files and other electronic document systems maintained by CROs and transfer local working copies as needed to support Receptos activities.
Assist with Internal study team meetings, as needed: prepare and distribute study team agendas and minutes, present information as requested.
Review study documentation, forms, manuals, etc. from CROs, ensure distribution and track review and response to CRO personnel as needed, create summary reports for clinical projects/programs, as requested.
Perform literature searches/reviews as necessary to gather background information for development of documents, training materials.
Maintain awareness of developments in clinical research by reading relevant literature, attending clinical team meetings, etc. Attend periodic training sessions to increase and maintain knowledge of FDA regulations, drug development process and regulatory documents requirements.
May assist with departmental or study-specific presentations (internal and external).