Clinical Trial Associate

Benefits

Qualifications

• •Have knowledge and experience with Trial Master Files (TMF) and experience with electronic TMF systems (e.g., Veeva)
• •Foundational knowledge of clinical research and/or experience in a research setting – not required but a bonus
• •Exceptional organizational skills and attention to detail; able to manage multiple priorities and timelines effectively
• •Strong written and verbal communication skills; ability to interact professionally within a cross‑functional team environment
• •Adept at learning new systems and technologies (e.g., eTMF, CTMS, or similar platforms)
• •Proficient with standard office software (Microsoft Office suite; Outlook, Excel, Word, PowerPoint)
• •Demonstrated ability to work independently and as a team player in a fast‑paced environment
• •Critical thinking and problem‑solving abilities
• •Ability to maintain confidentiality and adhere to high ethical standards
• •Solid computer skills in Office, Word, Excel, Project, Smartsheet, and other applicable applications
• •Ability to work in a fast‑paced environment with demonstrated ability to manage multiple competing tasks and demands
• •Excellent communication and interpersonal skills are essential as the CTA interacts with many people of varying levels of responsibility for clinical trial programs
• •Able to collaborate effectively with internal and external study management teams to meet project timelines
• •Excellent writing skills to assist with creation of file notes, team communications, and other documents as assigned
• •11 more items(s)

Responsibilities

• •The Clinical Trial Associate (CTA) is responsible for supporting the conduct of clinical trials and handling administrative aspects of clinical trial execution
• •This role will support completion of all study deliverables, ensuring the highest level of data quality; proactively identify, communicate, and resolve clinical study operational issues; and participate in process improvement initiatives as required
• •This role adheres to Clinical Standard Operating Procedures and Good Clinical Practice ICH Guidelines
• •Perform general administrative tasks to support team members with clinical trial execution, e.g., development and formatting of documents, review and reconciliation of study‑specific information
• •Assist in maintaining study status updates on a weekly basis
• •(e.g., IRB approvals, regulatory document collection, patient enrollment, monitoring status)
• •Track and prepare study‑specific information using databases, spreadsheets, and other tools
• •Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms
• •Manage clinical and non‑clinical supplies, including purchase and shipping
• •Help with the development and distribution of site binders
• •Set up and coordinate meetings, take and distribute meeting minutes
• •Support protocol and study‑specific training with vendors, site personnel, and clinical sites
• •Coordinate the movement of laboratory samples between clinical sites and central laboratories and track the status of samples and resulting laboratory data
• •Work with timelines and complete tasks according to deadline; problem‑solve study‑related issues; demonstrate resourcefulness and independence; and escape issues as needed
• •Assist/back‑up the Clinical Regulatory Operations Specialist for overall quality, maintenance, and completeness of Trial Master Files
• •Perform other duties as assigned
• •13 more items(s)