Contract Clinical Trials Associate (FD21-259)
Catalyst Biosciences is seeking a Contract Clinical Trials Associate in our South San Francisco office, reporting to our Director of Clinical Operations. The incumbent will be involved in all aspects of the overall operation of our clinical studies including project planning, budget, resource management and CRO management.
ABOUT CATALYST BIOSCIENCES
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet needs within bleeding and complement related disorders. Catalyst has compounds that span the value chain from early discovery to late stage clinical trials.
- Daily operations of studies to ensure compliance with applicable GCP/ICH guidelines and other regulatory requirements
- Work with cross-functional study teams, including vendors; liaise with other functional areas (preclinical, manufacturing, regulatory affairs) in order to accurately coordinate clinical study activities
- Coordinate clinical study timelines with project leaders to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
- Track study monitoring visits and co-monitoring visits as needed
- Provide updates of study progression
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
- Assist with data reports, presentations and study documents
**Title/Level to commensurate with experience.
- BA/BS degree with a minimum of 2 years of directly related experience or advanced degree (MS/PhD/PharmD) and 1 or more years of relevant experience
- General understanding of ICH/GCP guidelines and protocol and clinical drug development processes, clinical study design, study planning and management and monitoring
- Experience working with CROs and other vendors
- Attention to detail, excellent written and verbal communication, problem solving with various working assumptions, intangible variables and incomplete information
Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to email@example.com, referencing requisition number (FD21-259) in the subject line.