Clinical Trial Assistant (CTA)
About Inhibikase
Inhibikase is Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of pulmonary arterial hypertension (PAH).
Clinical Trial Assistant (CTA)
We are seeking a dynamic individual for the role of Clinical Trial Assistant (CTA) that can support the start-up and execution of clinical trials. The ideal candidate thrives in a fast-paced, small-company environment where daily activities can fluctuate, requiring prioritization, flexibility and the ability to navigate uncertainty. Reporting directly to Director level and above. The CTA supports the Clinical Trial Team in the planning, designing, executing, monitoring, and reporting of trial milestones. This may include creation of study documents, implementing and maintaining trackers, coordinating vendor payments and supplies, and support cross-functional study staff with related administrative activities. The CTA, under the direction and guidance of the Global Trial Lead will support and collaborate with other functional members as needed.
Responsibilities
- Acts as a central contact for the Clinical Trial Team for designated project communications, correspondence, and associated documentation.
- Supports the Clinical Trial Team cross-functionally as necessary to complete all study activities
- Supports the set up and maintain study specific electronic Trial Master Files
- Supports tracking of study specific training
- Performs Quality Control (QC) reviews of essential study documents and Trial Master Files (TMF) to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices
- Supports team in completing and reviewing of site documentation (CDAs, Contracts, Licenses, 1572s, CVs, Financial Disclosure forms, etc.)
- Prepares and tracks study documents (e.g., contracts, budgets, IRB documentation, sample management, etc.)
- Organize and/or participate in meetings internally and externally. Ensure appropriate meeting minutes are prepared, reviewed and filed in TMF
- Supports logistics and development of materials for Investigator Site meetings
- Can prioritize and use time efficiently to meet deadlines
Education and Training
- Associate degree or higher, with 1-3 years of relevant experience in Clinical Trial or related discipline in life sciences
- Knowledgeable at managing multiple tasks and multifunctional resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities
- Knowledgeable in Microsoft suite of products; Microsoft Word, Excel, PowerPoint, Outlook, etc.
Skills and Abilities
- Knowledgeable at ICH/GCP and applicable regulations
- Knowledgeable with the CDISC TMF reference model
- Able to communicate in written, verbal and face-to-face communication to present information internally and externally as needed
- Strong critical thinking and problem-solving skills
- Able to develop organizational, communication and presentation skills
- Detailed oriented
Inhibikase is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, veteran status, or any other status protected under federal, state, or local law.
Please send resumes and expression of interest to: careers@inhibikase.com
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