Clinical Study Associate Position Description
- This position will assist the Lead 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 Phase I through 4 clinical studies including registries and observational studies.
- 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, trainng 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 docuemtns tot eh 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 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
- 2 years previous industry experience
- Excellent interpersonal, written, verbal, presentation administrative and computer skills.
- Fluent in English (oral & written)
- Direct pharma experience
- General knowledge of drug development and ICH/GCP
- Responsible for complying with regualtions and guidelines and ensuring adherence to these during study conduct
- This position reports into a Global Development Operations Lead or Principal Clinical Study Manager
- 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.