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Senior Clinical Trial Associate
Liquidia Corporation. Assist with project start-up, including budgets, contracts, financial disclosure statements, and grant payments .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including oversight of project documents, compliance with ICH GCP regulations, and effective communication with study personnel. Proficient in maintaining study trackers and managing budgets, contracts, and financial disclosures.
Highest-signal resume keywords
Clinical Trials ManagementICH GCP RegulationsProject Document OversightBudget ManagementCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical OperationsDocument TrackingStudy Tracker DevelopmentTrial Master File MaintenanceInvestigator Site Regulatory DocumentsCase Report FormsMonitoring ReportsUser Acceptance TestingEDC SystemsInhalation Research
Soft Skills
Attention to DetailTime ManagementOrganizational SkillsMultitaskingInitiative
Tools & Technologies
CTMSClinicaltrials.govElectronic Document Management SystemsCommunication LogsTraining Logs
Industry Keywords
Phase 2 Clinical TrialsPhase 3 Clinical TrialsPulmonary HypertensionGlobal Clinical TrialsSponsor Experience
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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