we are looking for a FSP Clinical Research Associate I/ Clinical Research Associate II.
As part of our global team, you'll have the opportunity to perform and coordinate different aspects of the clinical monitoring and site management process. As a Clinical Research Associate I, you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
Requirements: Education and Experience Requirements:
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
1-2 years of experience as a Clinical Research Associate / Monitor
Valid driver's license where applicable
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role
Knowledge, Skills and Abilities:
Basic medical/therapeutic area knowledge and understanding of medical terminology
Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Good interpersonal skills
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
Good organizational and time management skills
Ability to remain flexibile and adaptable in a wide range of scenarios
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Ability to work in a team or independently as required
Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
This position is open to all candidates.