FSP CRA I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from a specific sponsor within FSP (functional service provider). Acts as a site processes specialist, ensuring 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. Ensures audit readiness. Develops collaborative relationships with investigational sites.

If based in Stockholm, the contract will be "hybrid" (50 % working from home, 50 % from the office/travelling). If based in other parts of Sweden, the contract will be fully remote.

Qualifications

Education and Experience

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.

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 flexible 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