Job Code: USCD10
Position: Clinical Research Associate (CRA)
Department: Clinical Development
Reports to: Executive Director, Clinical Development
Location: Bay Area, California
Connect Biopharma is a global, clinical-stage biopharmaceutical company founded by a team with broad knowledge of the drug discovery industry and expertise in targeting immunological pathways. The CRA is a critical part of a team within Clinical Operations responsible for quality oversight and execution of clinical trial activities. They will be responsible for some aspects of vendor management and will periodically represent CONNECT at Sponsor visits to clinical sites for monitoring or co-monitoring in collaboration with out-sourced CRO monitoring staff. The CRA monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. The CRA will collaborate closely with the CONNECT Clinical Operations staff to ensure study timelines are adhered to and required quality standards are maintained. The CRA is also responsible for facilitating good communication between CONNECT, the clinical site and the CRO.
- Conducts Sponsor Quality Oversight Visits (QOV), other monitoring or co-monitoring visits to clinical sites and vendors, as requested
- Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit) per monitoring plan and applicable SOPs in studies where these activities have not been sub-contracted to a CRO
- Collaborates with Clinical Operations Study Manager at the contracted CRO and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
- Manages site queries and communications
- Maintains and periodically audits study-specific records in the Sponsor’s Trial Master File
- Supports the Clinical Operations Study Manager to manage the clinical study sites, as required
- Establishes regular lines of communication with sites and reports site progress and issues to Clinical Operations
- Provides protocol and related study training to assigned sites
- Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate
- Attends regional investigator meeting and site booster visits, as required
- Helps to develop and reviews site specific recruitment materials and tools
- Monitors site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Authors or reviews monitoring plan and recruitment plan, if needed, for a given study that is reliant on in-house monitoring.
- Attends disease indication project specific training and general CRA training as required
- Facilitates site audits and/or inspections
- Documents monitoring activities appropriately by way of visit reports following ICH-GCP and CONNECT standards, as required for in-house monitoring.
- Assists with investigator/site identification
- Submits vendor invoices and tracks spending on vendor contracts for clinical trial execution
- Minimum of a BA/BS degree or equivalent and 5 years of experience in pharmaceutical development.
- Flexibility in adapting/reacting to changing company priorities and competitive or operational challenges
- Excellent planning and organizational skills
- Ability to interface with global clinical development teams and foster a collaborative and mutually supportive culture
- Initiative and leadership to interact with vendors and clinical site staff
- High sense of urgency and commitment to excellence in the successful achievement of objectives.
- The ability to perform in a fast-paced environment and be willing to take on additional challenges, willingness to stretch beyond and learn new skills to help the project team
Expected travel time up to 20% (but this will be curtailed until travel patterns normalize after COVID-19 pandemic)