This pharmaceutical organization develops therapies to tackle cancer and other serious diseases.
Title: Clinical Operations Clinical Trial Associate (CTA) — JO-2202-5736
Therapeutic Area: Oncology
The Clinical Trial Associate supports the planning, execution, and reporting for clinical studies and assigned trials to ensure on-time, on-budget delivery while maintaining compliance with Company processes, KPIs, quality standards, and local regulatory requirements.
Attention to detail and exceptional organizational and communication skills are required.
Reports to Head of Clinical Operations.
Essential Duties and Responsibilities
- Provide general administrative support to the Clinical team and assistance to Clinical Operations Project Manager(s).
- Assists the Clinical Operations Project Manager(s) with Sponsor oversight, study-specific documentation review, and quality control, including review of Informed Consent, study plans, study reference manuals, database, etc.
- Assist the Clinical team in the completion of all required tasks to meet departmental and project goals.
- Assist the Clinical operations Project Manager(s) with Sponsor oversight eTMFs periodic audit and findings resolution.
- Support management of third-party vendors.
- Assist with creation and maintenance of study metrics trackers, tools, and reports.
- Track the conduct of the trial, track and oversee progress and status, including but not limited to study startup, monitoring frequency, prompt site issue resolution, TMF maintenance, drug supply management.
- Attends internal and external team meetings/teleconferences and generates meeting agendas and minutes when needed.
- Assist with the tracking and distribution of safety reports as required.
- Assist with customization of Confidential Disclosure Agreement, clinical site contracts & budgets, when applicable.
- Track Vendors and/or internal Study Management Team performance against deliverables, contracts, and timelines.
- Assist project teams with trial registration by drafting the Clinical Trial.gov and ANZCTR registration submissions.
- Appropriately escalates issues in a timely manner and ensures resolution.
- Support the Director of Clinical Operations or delegate in the development and maintenance of clinical SOPs & trial process.
- Build a positive culture within clinical operations and cross-functionally.
Qualifications (Education & Experience)
- Bachelor’s degree in a biological or science-related or healthcare field.
- Previous 3 years CTA experience working with Sponsors/CROs and vendors.
- Career CTA preferred.
- Experience and knowledge of ICH GCP, eTMF management, and DIA TMF Reference Model.
- Strong Project coordination skills.
- Excellent verbal and written communication skills.
- Ability to work under pressure.
Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Affairs, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.