Remote Clinical Trial support resource II
1 Astellas Way Northbrook, IL 60062 US
- Associates Degree
- Must have at least 2 years previous experience in the healthcare or related field
- Pharma experience
- Must have excellent interpersonal, written, verbal, presentation administrative and computer skills.
- Fluent in English (oral and written)
Roles and 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 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 eTMF 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 Lead Study Manager to address challenges
- May participate in process improvement and quality-related initiatives associated with study execution and deliverables