Senior Clinical Trial Associate

🔥 11 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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Liquidia Corporation

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2004

🧬 Biotechnology

💊 Pharmaceuticals

💰 $75M Post IPO equity on 2024-02

Biotechnology • Pharmaceuticals

Liquidia is a biopharmaceutical company focused on developing inhaled therapies for rare cardiopulmonary diseases, particularly pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company leverages its proprietary PRINT® particle engineering technology to create proprietary formulations and delivery methods aimed at improving efficacy, tolerability, and convenience of inhaled medicines; its pipeline includes inhaled treprostinil (commercial product) and clinical-stage candidates such as L606. Liquidia emphasizes patient support, clinical development, and advancing therapies for improved respiratory outcomes.

📋 Description

• Assist with project start-up, including budgets, contracts, financial disclosure statements, and grant payments • Collaborate with Program Leaders to develop study-related materials, including informed consent forms, advertising materials, and study-plan sections • Assist in oversight, processing, and management of clinical project documents, including Investigator Site Regulatory Documents, Case Report Forms, and Monitoring Reports • Review CRO and vendor work and provide feedback to the study manager • Communicate with internal and external study personnel and maintain relationships with Investigators and study staff • Route Communication Logs, Training Logs, Protocol Deviation Assessments, and other study documents • Copy, distribute, and file Serious Adverse Event communications • Prepare and distribute project status reports, newsletters, and study event memorandums • Maintain electronic and paper document-tracking systems • 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 and follow up on discrepancies or missing documents • Assist in maintaining Standard Operating Procedures and Work Instructions • Assist in preparing Investigator Meetings • Update CTMS and clinicaltrials.gov systems • Assist with Trial Master File maintenance • Develop and maintain study trackers and provide metrics • Participate in user acceptance testing of clinical systems, including EDC and interactive response technology

🎯 Requirements

• Bachelor’s degree in related discipline • 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 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 • Proven ability to multitask • Efficient time management and strong organizational skills • Attention to detail and quality • Ability to travel up to 15%

🏖️ Benefits

• Competitive compensation package • Medical insurance • Dental insurance • Vision insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(k) Savings Retirement Plan • Employee Stock Purchase Plan (ESPP) • Equal opportunity employment • Reasonable accommodation for qualified individuals with disabilities

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