*Experienced CRA or SrCRA (f/m) - office or home based in Belgium
Conduct monitoring visits for assigned protocols and study sites. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
RESPONSIBILITIES 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 Project Manager (CPM), Clinical Research Specialist (CRS) 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, generating follow-up letters and other required study documentation.
May provide assistance to less experienced clinical staff.
- 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.
- 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, at least 1 year of on-site monitoring experience; or equivalent combination of education, training and experience
Good commands in English, Dutch and French and availability to travel will be required.
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