Location:Redwood City, California, United StatesJob reference:
Nov. 21, 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 Clinical Research Associate (CRA) provides day to day support to the Clinical Trial Manager in managing sites and vendors. This position is responsible for ensuring achievement of project goals and objectives.
The Clinical Research Associate will be responsible for assiting with developing clinical study protocols, case report forms, informed consent forms and other study-related documents. Will assist with study start-up, conduct and close-out activities and act as one of the primary contacts between the company and multiple clinical sites. Maintains close contact with sites by telephone, correspondence and on-site visits and participates in investigator meetings. Instructs investigators, study coordinators and their personnel in regard to study protocol, regulatory requirements and conduct of the study.
Additionally, the Clinical Research Associate arranges for the availability of adequate study supplies. Travels to clinical sites to monitor/co-monitor compliance with the study protocol, clinical trial material storage and accountability, GCP and FDA or other Health Authority regulations, and overall clinical objectives. Verifies accuracy of clinical data through comparison of the case report forms to patient records at the site. There will be approximately 30-40% yearly travel and selected candidate will interact with personnel at Clinical Research Organizations as needed.
* Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with 2 years' experience in clinical setting
* 2+ years of relevant clinical experience in a CRO or pharmaceutical industry
* Excellent communication, organization and tracking skills
* Strong operational skills and demonstrated ability to meet timelines
* Proven ability to work both independently and in a team setting, including a matrix environment
* Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process
* This position requires the ability to sit or stand for extended periods of time
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.