Clinical Trial Support Resource II Position Description
- 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, protol 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 tot eh TMF and ongoing document reconciliation.
- Assist in maintaining accurate as 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;
- Other duties as assigned
- Responsible for complying with regulations and guidelines and ensuring adherence to these during study conduct.
- This position reports into a Global Development Operations Lead or Principal Clinical Study
- 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 Preferred Direct pharma experience General knowledge of drug development and ICH / GCP
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.