Location:Redwood City, California, United StatesJob reference:
Nov. 18, 2016
Acerta Pharma is a leader in the field of covalent binding technology and is applying this technology to create novel, highly selective therapies for cancer. In February 2016, AstraZeneca acquired a majority share of Acerta Pharma via a USD $4 billion investment and is a committed partner to the development of these innovative drug candidates.
Acalabrutinib is Acerta's lead program which was developed based on our discovery efforts. It is an investigational covalent Bruton tyrosine kinase (BTK) inhibitor currently under investigation in multiple Phase 3 clinical trials. The clinical program includes over 20 trials in hematologic malignancies and solid tumors. Over 1,800 patients have participated in these trials to date.
The Senior Clinical Research Associate serves as a key role in the day to day management of a clinical trial. This individual will manage the study management team, vendors, clinical monitors, and clinical trials sites.
The Senior Clinical Research Associate will be responsible for designing and developing clinical studies and respective documents for company products. Assisting in the selection of investigational sites, negotiating grant contracts with each, and conducting site training for the study. Assisting in the setting and updating of study timelines. Assisting in CRO or vendor selection. May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports. Assisting in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies. Interfaces with individuals in other functional areas to address routine study issues.
Additionally, the Senior Clinical Research Associate may be asked to assist in the training of Clinical Trial Assistants. Conduct site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required. Assures site compliance with the routine protocol and regulatory requirements and quality of data. May resolve routine monitoring issues. Performs a site monitoring visit to assure protocol and regulatory compliance, and the timely submission of complete and accurate study data forms. Assures the creation of complete and accurate databases for clinical studies. Conducts analyses of study data and prepares clinical summaries as needed to support claims of safety and efficacy. Monitors case report forms, identifying and resolving discrepancies. Tracks clinical trial documentation and retrieves, processes and tabulates clinical or study compliance data to ensure smooth initiation, operation and timely completion of the clinical trial. The Senior Clinical Research Associate wii manage vendors as well.
* Bachelor's degree, typically in nursing or scientific field, or the equivalent
* 4+ years direct CRA experience in the pharmaceutical industry or equivalent in clinical study management
* Ability to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
* Possess excellent organizational skills
* Ability to effectively communicate and interact with key contributors including but not limited to physicians and clinical staff and to communicate technical information both verbally and in writing
* Ability to use a variety of software programs (MS Office)
* Ability to manage multiple tasks simultaneously
* Monitoring and/or site/ study management experience
* Demonstrated competence in standard business procedures (SOPs, Global Regulations)
* Experience in multiple phase (e.g., I, II, III) and multiple stage (e.g., startup, maintenance, close out) of clinical operations
* Experience in a regulatory environment
* May travel approximately 30-40% yearly
Next Steps -- Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.