Location:Redwood City, United StatesJob reference:
Sep. 14, 2016
Acerta Pharma was established in 2013 with a mission to discover and develop novel targeted molecules with the potential to improve patients' lives. At the core of our vision is a foundation based on cutting edge technologies, which enable the development of specific and selective drug candidates. Acerta's innovations translate to more effective and less toxic prospective therapies. As a member of the AstraZeneca group, Acerta is well positioned to rapidly achieve its first of hopefully several drug approvals to come.
The CTA/Sr. CTA is responsible for supporting the clinical study team in multiple areas. Acts as a central contact for the clinical team for designated project communications, correspondence and associated documentation. Perform administrative tasks to support team members with clinical trial execution as needed.
The CTA/Sr. CTA is responsible for monitoring clinical studies and sites for adherence to protocol, GCP and company SOPs. Ensures timely enrollment against plan, quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues. Maintains multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample tracking. Assists in the structure development of the TMF and filing system and is responsible for filing and maintaining up to date study documents. Assists in the design, format and content of CRFs study guides and subject instructions. Prepares, packages, and sends documents and materials to clinical trial sites and vendors as needed. Tracks and coordinates CRO and third-party vendor activities. Receives and reviews all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference, and maintains documentation as required. Ensures that regulatory documents are updated in a timely and appropriate manner. Assists with the development of site tools and clinical trial start up activities. Secures, with guidance from study lead, clinical trial insurance to support study start up.
Additionally, the CTA/Sr. CTA is responsible for coordinating Acerta's Contracts Approval Process, including obtaining appropriate approvals and signatures for all clinical Agreements in accordance with corporate policies to ensure compliance and standardization of process. Prepares, requests, and tracks Purchase Orders for contracted services across the clinical study(ies). Reviews subject visit schedules, site budgets, and clinical database to approve site payments. Confirms the accuracy of administrative data. Provides general support to the Clinical Operations team and performs other related duties and tasks, as required. Assists with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings. Maintains expertise through familiarity with clinical and scientific literature and participation in professional activities. Ensures compliance with Acerta's policies and procedures.
* Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory
* requirements preferred
* Excellent communication, relationship building and interpersonal skills
* Excellent organizational skills and ability to prioritize and multi task
* Proficient in Microsoft Office (e.g., Word, Excel, and Outlook)
* Bachelor's degree preferred
* 1-2 years' experience within the Pharmaceutical/CRO industry or equivalent site experience
* Requires the ability to sit or stand for extended periods of time.
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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.