CRA / Senior CRA Based In Sweden Or Denmark (Late Phase Dedicated)
Join us on our exciting journey!
IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
We are looking for experienced CRAs who are interested in monitoring of Late Phase trials.
As you advance your career as a CRA, this role is an ideal stepping-stone. It offers you a unique opportunity to expand your skills and experience in the realm of real-world and late phase research. You will also have training and development to plan and progress your career in the direction you choose.
Award winning and innovative, we will give you access to cutting-edge in-house technology, allowing you to work on global projects but with a regional / home state travel remit, so no need for national travel in certain countries. You will be building a smart and flexible career with no limits.
The position is home-based in the Nordics region (Denmark or Sweden).
As a Real-world evidence CRA you will have to ensure clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements by engaging with assigned sites.
May perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.
Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.
Execute assigned work efficiently and adhere to project timelines and financial goals;
Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
May assist in preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Strong written and verbal communication skills in applicable languages, and business level command of English
- Strong organizational, interpersonal and problem-solving skills
- Strong attention to detail
- Working time management skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites
- Ability to travel – approximately 30% of working time in average.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in life science and at least 1-2 years of monitoring/RSU experience
Fluent local and English language skills
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.
Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™.