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 CTA will support 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.
Essential Duties/ Responsibilities
* Assists study team with clinical study (ies) administration tasks and sites for adherence to protocol, GCP and company SOPs.
* Tracks timely enrollment against plan. Ensures quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues.
* Tracks the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample tracking.
* Assists in the development of the structure of TMF and filing system and is responsible for filing and maintaining up to date study documents.
* 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. Assists with guidance from study lead, clinical trial insurance to support study start up.
* Coordinates 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 on other clinical trial related duties and tasks, as required.
* Assists with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings.
* Ensures compliance with Acerta's policies and procedures.
* Demonstrates knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements.
* Possesses excellent verbal, written, interpersonal skills.
* Possesses good organization and planning skills.
* Proficient in Microsoft Office (e.g., Word, Excel, and Outlook).
* BA/BS/MS in a scientific discipline.
* 1-2 years' experience within the Pharmaceutical/CRO industry or equivalent site experience.
Next Steps -- Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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.
A little about us:
At AstraZeneca, we believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.