Clinical Trial Associate

Responsibilities

• Assisting with project start-up, including development of budgets, contracts, financial disclosure statements, and grant payments.
• Collaborating with Program Leaders to develop study-related materials (e.g., informed consent forms, advertising materials, sections of study plans, etc.) as required.
• Aid in the oversight, processing, and management of all clinical project-related documents including Investigator Site Regulatory Documents, Case Report Forms (CRF), and Monitoring Reports.
• Review the work of CROs and other vendors (Field Monitors, Central Labs, Clinical Supply Distributors, etc.) assigned to clinical studies to provide feedback to study managers.
• Communicate seamlessly and effectively with internal and external study personnel. Develop and maintain good working relationships with Investigators and study staff.
• Aid in the routing of Communication Logs, Training logs, and Protocol Deviation Assessments and other documents as required for the study.
• Prepare and distribute project status reports, newsletters, and study event memorandums.
• Support for maintaining both electronic and paper document-tracking systems for all documents associated with the start-up and execution of clinical studies.
• Review and verify investigator site visit grant calculations, prepare PO requisitions, and forward invoices, site payment letters, and expense reports.
• Follow up with CSM on any discrepancies or missing documents during the review of Investigator and Project files throughout a clinical trial.
• Aid in the maintenance of Standard Operating Procedures (SOPs) and Work Instructions.
• Assist in the preparation of an Investigator Meeting.
• Updates internal and external systems in a timely manner (CTMS, clinicaltrials.gov).
• Aid in the maintenance of the Trial Master File.
• Develop and maintain study trackers and provide metrics as needed.
• Participate in user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT).

Requirements

• Bachelor’s degree in related discipline and a minimum of 4 years of clinical trials or Sponsor experience in Clinical operations.
• Experience in Phase 2 to Phase 3 clinical trials including global clinical trials.
• Previous experience in any group of Pulmonary Hypertension or inhalation research is strongly preferred.
• Strong initiative and desire to work in a fast-paced, team-oriented, and dynamic environment.
• Excellent written and verbal communication skills and proven ability to multitask.
• Efficient time management and strong organizational skills. Attention to detail and quality are critical to success in this role.
• Ability to travel if required.

Benefits

• Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!

Disclaimer

• To ensure a fair and consistent evaluation process, candidates are expected to complete all interviews without the use of artificial intelligence (AI) tools, including but not limited to generative AI, real-time response assistance, or external prompting systems. Our interview process is designed to assess each candidate’s individual experiences, problem-solving abilities, and communication skills. We are committed to a people-centered recruitment approach. We do not use AI tools to automatically screen out or eliminate resumes during the application review process. All applications are reviewed by our recruiting team to ensure a thorough and equitable evaluation.
• Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.