Senior Clinical Research Associate (12-162) FibroGen
Join a growing Clinical team dedicated to support FibroGen?s first in class global anemia program consisting of three global Phase 3 studies. Located on a beautiful waterfront property in San Francisco, FibroGen is seeking Clinical Research Professionals who have a strong desire to contribute to the success of the program and utilize their skill set while expanding their knowledge base.
You will have the opportunity to proactively contribute to the development of processes that will impact the program. The successful incumbent will work closely with the Clinical Trial Managers, Medical Monitors and other key drug development functional units to ensure the successful completion of project deliverables. The successful candidate will:
Be technically adept
Have Sponsor experience
Be qualified in all aspects of study conduct including monitoring and site management
Have global and US start up experience
Be able to mentor junior staff
10 -30% travel required
Will possess operational management support experience
The Senior Clinical Research Associate is assigned to one clinical trial and a clinical trial team and leads various clinical operational aspects of the trial management in collaboration with other clinical team members. These activities include study start-up, vendor selection and management, interim study monitoring and management as well as trial closeout activities. This position typically reports to a Clinical Program Director (CPM) or an AD in Clinical Development.
A Sr. CRA is typically assigned to one trial and expected to:
Perform qualification, initiation, interim monitoring and closeout visits at clinical study sites for data collection, source data verification, review of regulatory documents/files and drug accountability
Manage assigned study sites and train the clinical site staff to ensure protocol and regulatory compliance
Participate in the CRO selection, management and budget negotiations
Participate in the clinical site budget and contract negotiations
May assist in or be responsible for development of protocols, informed consents, case report forms, monitoring plans, edit specifications, clinical study reports, and investigator brochures under direction of CTM/CPM.
Assist CPM / CTM with projection and management of clinical supplies
Coordinate and/or participate in investigator meetings
On assigned sites, interact with investigators in protocol development, presentations and publications
Responsible for updating study timelines and metrics
Provide mentoring to CRAs and Clinical Trial Assistants (CTA?s)
Bachelor?s degree in a relevant scientific discipline or equivalent
At least 5 years of relevant clinical experience in a CRA functional role in the pharmaceutical industry, Biotech or equivalent with 1 year experience as a Sr. CRA or equivalent preferred.
Knowledge of GCP and ICH guidelines required
Excellent communication and interpersonal skills
Able to work within a team
Able to perform assignments with general instructions
Proficiency with MS Word, Excel, Outlook, and PowerPoint
Must be willing to travel
||San Francisco, CA |