*(GFR) CRA Dedicated Team Home-Based & Remote Monitoring
When you work for Quintiles you work for the world’s leading pharmaceutical services company. No other pharmaceutical services company exceeds our record of experience and accomplishments. Recently, of the world’s top 30 best-selling drugs, Quintiles has helped to develop or commercialise every one.
Our competitive edge lies in the ability to leverage data, therapeutic expertise, full-service capabilities and global resources through an integrated information technology network. We hone our competitive edge by constantly scanning the horizon for opportunities and offering our customers the best information to accelerate and improve healthcare decisions. We operate in over 60 countries, and employ more than 19,000 people. We are the world’s leading Contract research organisation.
We currently have several opportunities for CRA and Sr CRA with exciting future prospects to develop further in our organisation.
We can only accept applications of Tri-Lingual Candidates (Dutch/French/English).
The key duties and responsibilities of the role include -
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
- May provide assistance to more less experienced clinical staff.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- In depth therapeutic and protocol knowledge as provided in company training
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
- Strong written and verbal communication skills including good command of English language
- Excellent organizational and problem-solving skills
- Effective time management skills
- Ability to manage competing priorities
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree in a health care or other scientific discipline, more than 1 year of on-site monitoring experience; or equivalent combination of education, training and experience
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