Job SummaryThe Sr. Clinical Trial Associate is a member of the Clinical Operations team. The Clinical Operations team is responsible for executing, managing, and conducting studies associated with the company's clinical development plans. This position requires coordination with all members of the Clinical Operations team as well as other internal and external team members.
Job Requirements- Bachelor's degree in related discipline and a minimum of 4 years of clinical trials or Sponsor experience
- Clinical operations experience in Phase 2 to Phase 3 clinical trials including global clinical trials.
- Working knowledge of ICH GCP regulations.
- Previous experience in any group of Pulmonary Hypertension or inhalation research 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 up to 15%.
Job 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.
- Assist in the oversight, processing, and management of all clinical project-related documents including Investigator Site Regulatory Documents, Case Report Forms (CRF), and Monitoring Reports.
- Reviewing the work of CROs and other vendors (Field Monitors, Central Labs, Clinical Supply Distributors, etc.) assigned to clinical studies to provide feedback to study manager.
- Communicating seamlessly and effectively with internal and external study personnel. Developing and maintaining good working relationships with Investigators and study staff.
- Assist in the routing of Communication Logs, Training logs, and Protocol Deviation Assessments and other documents as required for the study.
- Copy, distribute, and file Serious Adverse Event communications as required.
- Preparation and distribution of project status reports, newsletters, and study event memorandums.
- Provide 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.
- Review Investigator and Project files throughout a clinical trial and follow up with CSM on any discrepancy or missing documents.
- Assist 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).
- Assists with the maintenance of the Trial Master File.
- Developing and maintaining study trackers and providing metrics as needed.
- Participating in user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT).
Job BenefitsLiquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, and more!
