Clinical Research Associate
Well-funded Bay Area (South San Francisco) clinical stage biotechnology company is looking for an experienced Clinical Research Associate (CRA) who will be involved in assisting with the day to day management of multiple clinical studies in rheumatic diseases and autoimmune/inflammatory disorders.
The CRA will collaborate with both internal and external team members for the planning, execution and reporting of multiple Phase 1b and/or Phase 2 trials for our lead compound, KZR-616 (a selective inhibitor of the immunoproteasome).
This is an exciting opportunity to play a strategic role in the development of novel therapies for serious diseases.
Specific job responsibilities will include:
- Collaborate with cross-functional teams (research/clinical/regulatory, etc) to oversee activities dedicated to study design and execution
- Contribute to clinical study documentation including clinical protocols, investigator’s brochure, IND updates, clinical narratives and clinical study reports
- Coordinate specified clinical trial meetings (investigator meetings, study team meetings, CRO meetings), arrange logistics, prepare materials and record/distribute minutes
- Participate in the selection of vendors and Investigators; proactively manage vendors and perform site monitoring visits, as appropriate
- Maintain effective relationships with clinical collaborators and clinical site personnel
- Clinical sample management including but not limited to:
- Ensure necessary study supplies are available at sites, coordinating with vendors as needed (study manuals, lab kits, etc)
- Train clinical site personnel on laboratory procedures and manuals
- Coordinate, track and manage quality control, vendor utilization and shipping of clinical samples
- Analyze information, and utilize prior clinical experience and problem-solving skills to ensure the best possible outcome for the clinical research program
- Position may include up to 30% domestic and/or international travel
- Bachelor’s degree in a scientific field or equivalent and 3+ years of Clinical Research experience (Scientific background with proven ability to train laboratory personnel preferred)
- 2+ years of experience managing clinical studies, clinical samples, clinical documentation, clinical operations team interaction and clinical implementation methodology
- Sound computer skills: proficient in the use of Excel, Word, Project and PowerPoint; experienced with EDC systems; an aptitude for being able to train rapidly on new systems and facilitate the deployment of such systems to broader audiences. Competent in an electronic environment and the handling of documentation in such environments
- Ability to work with initiative and independence while exercising appropriate judgement when direction is required
- Thorough knowledge of ICH/GCP guidelines and FDA requirements for INDs and NDAs
- Attention to detail
- Ability to interact appropriately with clinical site personnel, and vendors, negotiating and motivating in a professional manner to achieve the right objectives in clinical project matters (finance, documentation or laboratory issues)
- Strong organizational, communication (oral and written), and interpersonal skills
- Time management, planning and project management skills
- An understanding of documentation management and document control workspaces (principles of audit trail and permissions control)
- Multi-tasking skills and ability to manage multiple competing tasks, tracking multiple deadlines and competing activities
If the thought of working in a start-up environment and making a major impact in drug development sounds appealing to you, please send your resume to firstname.lastname@example.org.