Job: Sr. Clinical Research Associate/Clinical Trial Manager

Location: Sunnyvale, CA

About the Job

Please note this is a FULL TIME PERMANENT position.

Skills:Clinical Trial experience, Clinical Studies, BS/BA -RN Degree, Global Trial Preferred, FDA Regulations
Key Accountabilities/Core Job Responsibilities:

• Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
• Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
• Develop study budget and timelines
• Prepare regulatory documents and submissions
• Execute project specific training for internal and external staff
• Maintain Trial Master File
• Manage Investigational Product (IP)
• Manage safety reporting
• Procure and manage contracts with CROs, study vendors and investigative sites
• Provide oversight of CROs, independent field monitors and other clinical vendors
• Review monitoring trip reports and track resolution of all action items
• Co-monitor at investigative sites to evaluate study site and field monitor performance
• Collaborate with medical experts, clinical study sites, and clinical study vendors
• Performs in-house review of clinical database listings for completeness and accuracy
• Develops clinical study reports

Qualifications:

• Excellent verbal and written communication skills
• Attention to detail
• Able to organize, manage and set priorities for multiple tasks
• Strong leadership skills, self-motivated, adaptable to a dynamic environment
• Able to collaborate effectively with the study team, cross-functional team members, and external partners
• Knowledge of ICH/GCP and FDA regulations
• Proficiency in MS Word, Excel and Powerpoint
• Able and willing to travel approximately 25-30%

Experience:

• 6+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience)
• Experience in oncology preferred
• Experience in global trials preferred
• Experience with Electronic Data Capture systems preferred

Education Requirements:

• BS/BA degree in a life science, RN, or related field

Abilities

On a continuous basis, sit at desk for prolonged period of time at company facility to intermittently answer telephone, file/fax/or copy documents, and write or use a keyboard to communicate through written means. Walking and lifting up to 20 pounds may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
For consideration please include job # 189

More Info and Application