Senior Clinical Research Associate (13-111) FibroGen
FibroGen seeks a highly experienced Senior CRA with in-depth knowledge of Phase I through III Clinical Trials. The successful candidate will, working closely with the Clinical Program Manager, be responsible for the planning, implementation, monitoring and site management of clinical studies.
Candidate must have in-depth experience in conducting pre-study, site-initiation, monitoring, and closeout visits. Candidate may be responsible for training of CRAs/CRO in conduct of such visits.
Responsibilities may include managing clinical supplies, working with/managing CROs, recruiting investigators, organizing investigator meetings, setting up internal central systems as needed, assist in writing study protocols, final study reports, SOPs, expedited/annual safety reports, and designing and implementing CRF's. Duties also include liaison activities with manufacturing and multiple project group members.
Requires a BS, RN, or RPh and 5+ years of related clinical experience. Requires knowledge of FDA, ICH and GCP guidelines.
This is a very hands-on position in a very small start-up clinical group. Multitasking, ability to work independently, excellent interpersonal and communication skills are critical, as is flexibility and strong attention to detail. Ability to travel when required
||San Francisco |