Careers
Clinical Research Associate (CRA-420)
Ambit Biosciences is engaged in the discovery and development of small-molecule kinase inhibitors for the treatment of cancer. With more than 500 distinct kinases identified and over 30 kinase inhibitors in clinical trials or FDA approved, this important class of proteins is a rich area for therapeutic drug development. We have an opportunity for a contract opportunity for a Clinical Research Associate.
RESPONSIBILITIES:
The Clinical Research Associate will monitor 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. Responsibilities will include, but are not limited to:
- Acting as main line of communication between the sponsor and the Investigator
- Traveling approximately 50% of the time, work alone at sites, and arrange own schedule, for qualification, initiation, routine and study close-out monitoring visit
- Assisting in the creation and implementation of protocols, informed consents, case report forms, clinical study reports, and related study materials
- Providing 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
- Coordinating 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
- Ordering study supplies
- Maintaining tracking tools
- May assist with site budget negotiations
REQUIREMENTS:
- BS or MS in a relevant scientific discipline or health related field.
- Two plus (2+) years of clinical operations experience in biotech/pharmaceutical industry. Oncology experience highly preferred.
- Solid demonstrated knowledge of GCP and ICH guidelines, FDA regulatory requirements and quality assurance procedures.
- Excellent computer skills which include MS Word, MS PowerPoint, MS Excel, MS Outlook.
- Requires excellent interpersonal skills as the job necessitates interaction with a variety of individuals (physicians, nurses and study site personnel)
- Travel up to 50%