Clinical Research Associate IV
One DNA Way South San Francisco, CA 94080
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
- Development and/or writing study documents (protocols, protocol amendments, CRFs, investigational brochures, annual report, study guidelines, etc.) • Qualifying, monitoring and managing sites including co-monitoring with the CRO • Management of various CROs and vendors involved in the study (e.g. monitoring, data management, central labs, etc) • Implementation of operational activities and project management tasks associated with clinical studies (eg. central lab coordination, SAE tracking/reconciliation, etc.) to ensure they are conducted in a successful, timely manner and within budget • Responsible for all start-up activities including but not limited to: site selcetion, drug preparation, enrollment, data collection, etc. • Proactively identifying solutions when issues arise • Organization of investigator, steering committee, and data monitoring committee meetings • Assist with CRO and vendor identification and selection process • Management of key study parameters (e.g. start-up activities, drug preparation, enrollment, data collection, etc) • Implementation and management of operational plans • Data review (patient profiles, line listings, patient narratives, etc.) • Preparation of study updates • May take on timelines and budget management, as applicable
- 4-5 years in the pharmaceutical industry including in-house experience • Solid, hands-on clinical trial experience including site monitoring • Strong organizational and oral and written communication skills • Solid experience developing/writing study documents (protocols, annual reports, etc.) • Ability to work as a team player and the ability to work in a fast-paced environment • Must be flexible, detail-oriented and have an interest in professional growth • Energetic, self-starter, able to multi-task and be proactive • Some travel required
- BS/RN degree or equivalent in the scientific or health care field (e.g. Nursing, Pharmacy, etc.)