Astellas Pharma Clinical Study Associate in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company. Astellas is announcing a Clinical Study Associate opportunity in Northbrook, IL.
Purpose & Scope:
This position will assist the Study Manager and the clinical team in the day to day activities for managing clinical study(ies) conduct to support completion per established project team goals and objectives. The scope of this position is CPED-responsible clinical studies.
Essential Job Responsibilities:
Assist in the day to day support of study operations including tracking and creating overviews of subject, site, study status, milestones and performing quality check activities across components of the clinical study.
Assist in study set-up including but not limited to eCRF design, protocol preparation, informed consents, investigator selection, systems (e.g., CTMS, IVR, etc.), study related operational manuals, training materials, and various study plans (e.g., visit logs, drug inventory, monitoring plan, etc.).
Process and track clinical trial materials requests, study related supply requests, safety letters, vendor and investigator contracts and payments and other study related activities as needed.
Assist in the management of study completion activities including data review and clinical study report review.
Ensure complete and timely collection and archiving of TMF documents of assigned studies or program, including oversight and/or submission of regulatory documents to the TMF and ongoing document reconciliation.
Assist in maintaining accurate and up to date study information within CTMS and other relevant tracking systems.
Effectively communicate with study team members and work closely with Study Manager to address challenges.
May participate in process improvement and quality-related initiatives associated with study execution and deliverables.
Other duties as assigned
Responsible for complying with regulations and guidelines and ensuring adherence to these during study conduct.
This position reports into an Associate Director or Director, CPED
Must have at least 2 years previous experience in the healthcare field
Must have excellent interpersonal, written, verbal, presentation administrative and computer skills
Fluent in English (oral and written)
Minimal (10%) travel required
Direct pharma experience
General knowledge of drug development and ICH / GCP
Category Clinical Pharmacology and Exploratory Development (CPED)
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans