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Senior Clinical Research Associate (Anemia)
(Job Code: 7HR206)
FibroGen currently seeks an in-house Senior Clinical Research Associate
to join our Renal Anemia Clinical Team (Dialysis).
General Position Description:
The Sr. Clinical Research Associate (CRA) will be responsible for
initiation, monitoring and other tasks associated with clinical
studies. The Sr. CRA will be responsible for investigational site
management for clinical studies, and will assist in the creation and
implementation of protocols, informed consents, case report forms,
clinical study reports and related study materials. He/she will also
provide guidance, clinical trial management and direction to contract
CRAs in the field.
Project Specific Responsibilities for the Sr. Clinical Research
Associate:
The Senior CRA will actively participate in clinical trial activities
from study start-up through closure
Assist the CPM with vendor management including the CRO (monitoring
and data management), central laboratory, and IVRS vendors
Work with CRO and manage site selection process
Assist with reviewing and editing study documents such as Study
Operations Manual, Study Drug Manual, Project Management Plan,
Communication Plan, Monitoring Plan, and Data Management Plan
Prepare and review study tools such as the Source Document Worksheets
and Source Data Verification Worksheets
Assist with protocol development, study report completion and
designing CRF's
Accompany CRO CRAs to monitor activities at clinical study sites to
assure adherence to Good Clinical Practices (GCPs), SOPs and study
protocols
Order and co-ordinate study supplies
Develop and maintain tracking tools
Assist with CRO selection and management of CRO's and other vendors
May assist with site budget negotiations
Plan and participate in investigator meetings
Assist and support data validation and data clean procedures
Assure regulatory compliance of investigational sites with SOPs and
FDA and ICH guidelines
Requirements:
BS in the life sciences or health-related field and 5+ years of
relevant experience.
Demonstrated working knowledge of GCP, ICH guidelines and FDA
regulations.
Experience managing CROs and vendors.
Demonstrated ability to work independently and on a team.
Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
and clinical trial software.
Excellent oral and written communication skills, and strong
organizational abilities.
Anemia, Diabetes or Renal experience preferred.
Minimal Travel as required by team/study need.
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