Careers
Sr. Clinical Research Associate (SCRA-418)
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 talented Sr. Clinical Research Associate.
RESPONSIBILITIES:
The Sr. 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:
- Contribute to the development of protocols, case report forms (CRFs), informed consent forms, and investigator’s brochures. Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual.
- Review regulatory documents, as required. Create study-specific source documents, guidelines, and forms to effectively implement protocols.
- Track data forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites.
- Identify and resolve problems at assigned investigative sites to ensure subject safety and the highest possible data quality.
- Participate in the selection/negotiation and management of activities of CROs, other service providers and investigative sites.
- Participate in the preparation/coordination of investigator meetings, including preparing and delivering presentations. Provide clinical expertise to department members and to other cross-functional areas.
- Perform pre-study site qualification, initiation, monitoring, and closeout visits. Identify and recommend any needed corrective actions.
- Schedule, administer budget and timelines and ensure timely delivery of final reports for regulatory submissions.
- Serve as liaison between all internal and external personnel involved with the study, including contract research organizations, investigative sites, study team, and vendors.
- Attend site/CRO QA audits, as required.
- Generate and distribute project team meeting minutes.
REQUIREMENTS:
- BS degree in a life science preferred or its equivalent in health care or biological science.
- Minimum of 5 years of clinical operations experience in the biotechnology or pharmaceutical industry. Oncology experience highly preferred
- Strong working knowledge of Good Clinical Practices (GCP); ICH guidelines; trial initiation and management practices and procedures;
- Knowledge of pharmaceutical industry Standard Operating Procedures (SOPs)
- Proficiency in Lead CRA skills:
- Interpretation of clinical study protocols
- Designing case report forms to capture data per protocols
- Patient Informed Consent preparation and review
- Study initiation document preparation
- Strong communication skills, both oral and written
- Excellent interpersonal skills as the job necessitates interaction with a variety of individuals (physicians, nurses, management, legal personnel, Ambit management etc.)
- Willingness to travel up to 40%