Title: Clinical Research Associate
As a CRA you will be responsible for the successful conduct of clinical trials and serve as main contact for the investigative site by representing Clinart in a professional manner.
What You’ll Do
- Serve as main Clinart contact for assigned study sites
- Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP
- Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection
- Collect, review and track essential/regulatory documents
- Participate in and complete all general and study specific training as required
- Participate in investigator, client and project team meetings; may include presentations
- Create and implement subject enrollment strategies for assigned study sites
- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
- Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan
- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
- Assist with project-specific activities as member of Project Team
What You Bring
- 3 years clinical research experience as a CRA or related profession
- Life science background
- Excellent knowledge in ICH-GCP and regulatory requirement
- Strong written and verbal communication skills including fluency in English are required.
- Effective time management skills with ability to manage competing tasks.
- Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected.
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment