Clinical Trial Associate (Contract)

*1099 Consultant Opportunity*

Duration: 5-6+ months

Hours: 35-40+ hours/week

Location: Remote w/ US travel

Clora's client is a biotechnology company focused on immuno-oncology. The Clinical Trial Associate (CTA) has hands-on responsibility for the day-to-day coordination of activities within the clinical trial team; supports the trial team with the planning, start-up, execution and close-out of trial activities and deliverables. The CTA also supports and coordinates activities of clinical teams and programs (all phases) in the field of Immuno-oncology and other therapeutic areas as appropriate; supports the trial teams in the management, planning, and execution of clinical trials, including administrative aspects in the execution and management of clinical trials creating and overseeing tools for tracking of trial status, documentation, etc.

Responsibilities:

• The CTA supports the trial team with the planning, start-up, execution and close-out activities and deliverables. Conducts all tasks in accordance with applicable Company Policies, Guidelines, Quality Documents, Standard Operating Procedures (SOPs), Working Instructions (WIs), and other Guidance and Standards, as well as current Good Clinical Practice (ICH-GCP) and applicable national regulations.
• Drafts and/or assists with the preparation of trial-related documents, tools and templates (start- up forms, ICFs, screening scripts, source documents, study logs). Supports the trial team in the management, planning, and execution of clinical trials, including administrative aspects in the execution and management of clinical trials, creating and overseeing tools for tracking of trial status, documentation, etc.
• Liaises with key members of the trial and project team, both internal and external, including study site investigators and coordinators, monitors/clinical research associates and data managers and Clinical Research Organization (CRO) staff. Supports CTM (or designee) on trial documentation handling, site and vendor payment processing, and clinical trial administrative tasks during the planning, execution, and management of in-house/outsourced or hybrid model clinical trial(s).
• Ability to be onsite with Clora's client in Lexington, MA for initial onboarding and then as needed for onsite meetings during the duration of the project. Ability to travel as needed domestically and internationally.