Associate Director, Biostatistics
Amgen
Flash
Clinical Research Associate II – CNS/Psychiatry
Worldwide Clinical Trials
full-time
Posted on:
Origin: • 🇺🇸 United States • North Carolina
Visit company websiteJob Level
JuniorMid-Level
About the role
- Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
- Ensure completeness and compile regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB approval, informed consent, lab certification etc.)
- Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
- Perform feasibility studies/site identification activities for potential sites, as requested
- Play a lead role in execution of clinical research programs, driving scientific research and ensuring quality and excellence
Requirements
- Bachelor's Degree or a Nursing Degree required
- Minimum of one year experience as an In-House CRA or Clinical Research Coordinator (CRC) required
- CNS experience highly preferred, preferably with Psychiatry experience (Bipolar or Schizophrenia)
- Excellent interpersonal, oral, and written communication skills in English
- High level of proficiency in both spoken and written English required
- Ability to contribute to a team remotely
- Strong customer focus, ability to interact professionally with sponsor contacts
- Proficiency in Microsoft Office, CTMS, and EDC Systems
