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