About this role
As Clinical Research Associate II / Senior CRA at CTI, serve as the main contact for assigned study sites. Conduct site visits including pre-study (PSV), site initiation (SIV), interim monitoring (IMV), and close-out (COV). Complete deliverables with quality and within timelines outlined in the Monitoring Plan, adhering to regulatory requirements, SOPs, and ICH GCP.
Assist with or oversee study start-up activities like feasibility, pre-study tasks, and site selection. Collect, review, and track essential and regulatory documents. Participate in investigator, client, and project team meetings, potentially including presentations, while completing all required training.
Create and implement subject enrollment strategies for sites and ensure proper storage, dispensation, and accountability of Investigational Product (IP). Perform site management activities with ongoing updates to the Clinical Project Manager. Conduct remote monitoring per the study-specific Monitoring Plan and utilize systems for tracking subject status, CRFs, SDV, documents, and IP.
Join a global team spanning 60 countries with an award-winning culture prioritizing people. Benefit from hybrid work opportunities and the CTI Cares program for community impact. Advance medicine by contributing to life-changing treatments for patients with chronic and critical illnesses.
Invest in professional growth through structured mentoring, leadership development courses, and a dedicated training department. Encourage ongoing education to achieve career goals. Make a lasting impact while moving medicine forward for those who need it most.
Requirements
- 3-5 years clinical research experience as a CRA or related profession in Germany including independent monitoring experience in Germany
- Life science background
- Excellent knowledge in ICH-GCP and regulatory requirements
- Fluent (at least Level B2) in spoken and written German and English
- Familiarity with Monitoring Plans, SOPs, and EU regulatory compliance for clinical trials
Responsibilities
- Serve as main CTI contact for assigned study sites
- Conduct site visits (PSV, SIV, IMV, COV) and complete site visit deliverables with quality and within timelines
- 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 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
- Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan
Benefits
- Structured mentoring program, leadership development courses, and dedicated training department
- Ongoing education support to achieve professional goals
- Global team spanning 60 countries with award-winning culture
- Hybrid work opportunities supporting work-life balance
- CTI Cares program for giving back to community and world
- Contribute to developing life-changing treatments advancing medicine
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