Cra 2 - Courbevoie, France - IQVIA
Description
PURPOSE
Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and
needs to enhance predictability.
RESPONSIBILITIES
- Perform site selection (if applicable), initiation, monitoring and closeout visits in accordance with contracted scope of work
- 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
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment,
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by
- Build awareness of features and opportunities of study to site.
- Collaborate and liaise with study team members for project execution support as appropriate.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice
- Strong 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
- Strong organizational and problemsolving skills
- Effective time management skills
- 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 or educational equivalent and 1 year of onsite monitoring
PHYSICAL REQUIREMENTS
- Extensive use of telephone and facetoface communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Requires frequent travel to sites
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