Sr. Clinical Trial Associate

Liquidia • ,

3d

About The Position

The Sr. Clinical Trial Associate is a member of the Clinical Operations team, which executes, manages, and conducts studies in support of the company’s clinical development plans. The position coordinates with Clinical Operations team members and other internal and external personnel, supporting clinical studies from start-up through execution and closeout-related activities. The role includes managing study documents and systems, supporting budgets and site payments, reviewing CRO and vendor work, maintaining study trackers and the Trial Master File, and assisting with study meetings and clinical systems testing. Travel of up to 15% may be required.

Requirements

• Bachelor’s degree in a related discipline.
• At least 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.
• 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.
• Ability to travel up to 15%.

Nice To Haves

• Previous experience in pulmonary hypertension or inhalation research is strongly preferred.

Responsibilities

• Assist with project start-up, including developing budgets and managing contracts, financial disclosure statements, and grant payments.
• Collaborate with Program Leaders to develop study materials, including informed consent forms, advertising materials, and sections of study plans.
• Assist with oversight, processing, and management of clinical project documents, including Investigator Site Regulatory Documents, Case Report Forms (CRFs), and Monitoring Reports.
• Review work from CROs and other vendors, including field monitors, central laboratories, and clinical supply distributors, and provide feedback to the study manager.
• Communicate with internal and external study personnel and develop and maintain effective working relationships with investigators and study staff.
• Assist with routing communication logs, training logs, protocol deviation assessments, and other study documents.
• Copy, distribute, and file Serious Adverse Event communications as required.
• Prepare and distribute project status reports, newsletters, and study event memorandums.
• Support electronic and paper document-tracking systems for documents related to clinical study start-up and execution.
• Review and verify investigator site visit grant calculations; prepare purchase order requisitions; and forward invoices, site payment letters, and expense reports.
• Review investigator and project files throughout clinical trials and follow up with the CSM regarding discrepancies or missing documents.
• Assist with maintaining Standard Operating Procedures (SOPs) and Work Instructions.
• Assist with preparation for Investigator Meetings.
• Update internal and external systems, including CTMS and clinicaltrials.gov, in a timely manner.
• Assist with maintaining 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).

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Short-term disability (STD)
• Long-term disability (LTD)
• 401(k) Savings Retirement Plan
• Employee Stock Purchase Plan (ESPP)
• Competitive compensation package

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level