Clinical Research Associate II (CRA II) (11-132) FibroGen

Description:
Reporting to a Clinical Program Manager (CPM), the successful incumbent will assist with operational activities for two phase two trials in China. The therapeutic area is anemia.
Duties include, but are not limited to:

May monitor study sites for data collection, source data verification, review of regulatory documents/files and drug accountability
May review and edit documents including protocols, informed consents, case report forms, monitoring plans, edit specifications, abstracts, presentations, manuscripts and clinical study reports
May write protocols and protocol amendments, with supervision
Will present at investigator meetings
May manage CROs and/or contract CRAs with guidance from CPM
Chair or participate in meetings or conference calls with CROs and multi-disciplinary study team
Assist in review of data and preparation of safety, interim and final study reports, and resolution of data discrepancies
Assist in setting and updating study timelines
Participate in abstract preparation, presentation preparation and manuscript development
Train clinical site staff to ensure protocol and regulatory compliance. May assist in training CRA I and CRA Assistant

Job Requirements:

Bachelor?s degree in a relevant scientific discipline or equivalent
At least 2 years of relevant experience as a CRA in the biotech / pharmaceutical industry. 3+ years CRA experience is preferred
Knowledge of GCP and ICH guidelines
Excellent communication and interpersonal skills
Ability to work collegially within a team
Able to perform routine assignments with general instructions and new assignments with detailed instructions
Proficiency with MS Word, Excel, Outlook, and PowerPoint
Must be willing to travel (10-15%)
Ability to speak Mandarin is highly desirable

Location:	San Francisco, CA United States