Make a Difference. Every Day.

Do you want to use your experience as a CRA in a highly specialized academic environment where research and clinical care meet? We are now looking for an experienced monitor for a part-time position in our clinical research unit within oncology and hematology.

The field of hematology, oncology, and radiation physics is one of the largest at Skåne University Hospital. The clinical research unit is shared between hematology and oncology and conducts both academic and industry-sponsored studies from First-In-Human and phase 1 to phase 4.

We work closely with clinical care in Lund and Malmö as well as with Lund and Malmö universities. Our goal is to conduct research of the highest quality that contributes to the development of future cancer and blood disease treatments. The unit employs approximately 40 staff members from various professions and currently runs around 100 ongoing studies.

RESPONSIBILITIES

As a CRA/Monitor with us, you will play a central role in ensuring quality, patient safety, and regulatory compliance in our clinical studies. The work is independent and varied, with opportunities to contribute both operationally and advisory to the study organization.

Responsibilities include:

• planning, conducting, and following up on monitoring visits at trial sites
• central monitoring with ongoing review of study data and data quality
• source data review and risk-based monitoring according to ICH-GCP
• identifying, documenting, and following up on deviations
• providing support and advice to study personnel on issues related to study conduct and regulations

Travel within the position is required. This advertisement refers to a part-time position corresponding to approximately 25 percent of a full-time role.

QUALIFICATIONS

We are looking for someone who has:

• a university or college degree in life sciences, medicine, health sciences, pharmacy, or another relevant field
• at least 2 years of documented experience working as a CRA/Monitor
• good knowledge of ICH-GCP and applicable regulations
• very good proficiency in Swedish (at least level C1) and good proficiency in English, both spoken and written
• good computer skills and proficiency in the Office suite

Experience in clinical studies within oncology and/or hematology is an advantage.

As a person, you are structured, meticulous, and independent, with a good ability to communicate and collaborate with various professional roles.

We apply ongoing selection. We warmly welcome your application today! Please note that this advertisement has been published under several different locations/job categories linked to a main advertisement. Therefore, you may be redirected when applying for the job.

ADDITIONAL INFORMATION

Region Skåne is responsible for healthcare, public transport, and sustainable development throughout Skåne. Our highest decision-making body is the regional council, which is directly elected by the residents of Skåne. Region Skåne is a values-driven organization that works with the values of welcoming, driving, care, and respect in everything we do.

Skåne University Hospital (Sus) is located in Lund and Malmö and is the country's third-largest hospital. Sus is a knowledge hub for healthcare at all stages of life at regional, national, and international levels. Our 12,000 employees are involved in driving the development within the university hospital's three mission areas: care, research, and education. With us, you will work in a values-driven organization that develops healthcare together with patients and their relatives. Welcome!

At https://www.skane.se/ledigajobb (https://www.skane.se/ledigajobb), you can see the status of Region Skåne's recruitments and how many have applied for the positions.

If you have protected personal information, please contact the contact person specified in the advertisement so that your application can be handled according to special procedures. When you apply for a job at Region Skåne, your application becomes a public document under the principle of public access. The information is processed and stored according to the General Data Protection Regulation (GDPR).

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