Position Summary
The Clinical Trial Assistant (CTA) provides administrative and clinical trials assistance to the Project Managers, Clinical Trial Managers, Clinical Research Associates (Site Monitors), and other roles as needed on the various tasks associated with running a clinical trial. Generally, the CTA is responsible for all administrative tasks and assisting the project team in the start-up, execution and close-out of the trial in accordance with the Federal Code of Regulations, Good Clinical Practices, ICH Guidelines, SOPs, etc. The CTA works collaboratively with Compliance, Regulatory, Clinical, Legal, CMC and Finance functions. The CTA reports to the Vice President, Clinical Operations.
Summary of Key Responsibilities
• Provide support to the project team throughout the conduct of clinical trials.
• Communicate and follow up on actions between vendors, sites, and the project team.
• Assist with start-up activities to include site regulatory document collection.
• Update and maintain clinical systems within project timelines.
• Prepare, handle, distribute, file, and archive clinical documentation and reports.
• Review of study files periodically for accuracy and completeness.
• Prepare, handle and distribute of Clinical Trial Supplies and maintenance of tracking information.
• May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Perform administrative tasks to support team members with clinical trial execution as needed.
• Assist sites with preparation for planned and unannounced audits with some guidance.
• Organize project meetings and tracking of action items, decisions, etc.
• Track and reconcile essential documents for Trial Master File according to ICH GCP and company SOPs/policies
• Maintain appropriate professional relationships utilizing an assertive, business-like manner which fosters study compliance.
• Other company-related projects and tasks as assigned.
Qualifications
• Authorized to work lawfully in the U.S.
• Bachelor’s degree (preferably in nursing, pharmacy or other allied health care discipline including appropriate certification/licensure (i.e., RN, RT, PA, or RPh), or life science field (i.e., biology, chemistry, zoology, etc.).
• Minimum of 1 year of directly related experience and extremely strong clinical knowledge.
• Proficiency in Microsoft Office Suite Software, CTMS, EDC, and eTMF.
• Knowledgeable in clinical trial processes and systems applications to support operations.
• Knowledgeable of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
• Strong organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
• Excellent communication (written and verbal) and presentation skills along with leadership qualities.