Sr. Clinical Research Associate Ambit Biosciences
The Clinical Research Associate assists with operational activities within the clinical development department and monitors clinical trials at investigative clinical sites to verify that the rights and well-being of human subjects are protected, the reported trial data are accurate, complete and verifiable from source documents and to assure compliance with the protocol(s), with Good Clinical Practices (GCP), ICH guidelines and with applicable regulatory requirements.
Essential Job Functions:
?Assist in the creation and implementation of protocols, informed consents, case report forms, clinical study reports, and related study materials
?Provide guidance, clinical trial management, and direction to contract CRAs in the field
?Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual
?Coordinate and be responsible for the completion of study documentation materials such as CRFs and study reports
?Assure regulatory compliance of investigational sites with SOPs and FDA and ICH guidelines
?Assist with protocol development, study report completion, and designing CRFs
?Monitoring activities at clinical study sites to assure adherence to GCPs, SOPs, and study protocols
?Coordinate, order, and track required laboratory supplies, and other study materials
?Maintain various tracking tools
?May assist with site budget negotiations
?Travel up to 25% of the time, work alone at sites, and arrange own schedule, for qualification, initiation, routine and study close-out monitoring visit
?Completes other tasks as requested by Clinical Development management staff
Essential Job Requirements:
EDUCATION:BS or MS in a relevant scientific discipline or health related field.
EXPERIENCE:Minimum of five (5) years of relevant experience as a CRA monitoring Phase I ? III clinical studies and managing clinical study sites. Oncology trial experience preferred.
COMPETENCIES AND SKILLS:?Solid demonstrated knowledge of GCP and ICH guidelines, FDA regulatory requirements and quality assurance procedures
?Requires excellent interpersonal skills as the job necessitates interaction with a variety of individuals (physicians, nurses and study site personnel)
?Creative problem solving and critical thinking skills
?Can operate easily in a fast-paced team environment
TECHNICAL KNOWLEDGE:Equipment: PC, scanners, facsimile machine, voice mail and email systems, and other common machines. Must have the ability to be trained on new equipment.
Software Knowledge:Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe.
Physical Activities: While performing the duties of this job, the employee is frequently required to sit at desk for a long period of time; intermittently answer the telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The employee may need to use their hands to finger, handle, or feel objects, tools, or controls, and reach with their arms. The noise level in the work environment is usually low to moderate. The vision abilities required by this job include close vision and the ability to adjust focus.
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.
Laboratory Activities, if applicable: Experience with biological, animal, and chemical laboratory environments required. Environmental health and safety processes also apply.
||4215 Sorrento Valley Boulevard |
San Diego, CA 92121