"Junior or Senior CRA (f/m) - based in Denmark"
You have collected experience as a CRA or you are you an experienced study coordinator/study nurse who would like to do the next step in career? – So this is the great opportunity to join Quintiles Denmark as a Junior CRA (f/m) or CRA (f/m)!
The Danish Quintiles office is located in Hellerup near Copenhagen and we are also offering home-based positions throughout Denmark.
Conduct monitoring visits for assigned protocols and study sites. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements
- Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
- Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness.
- Assist CRS/iCRS, CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
- May perform assigned administrative tasks to support team members with clinical trial execution.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Good therapeutic and protocol knowledge as provided in company training
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
- Good written and verbal communication skills including good command of English language
- Good organizational and problem-solving skills
- Effective time management skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree in a health care or other scientific discipline or educational equivalent, and successful completion of a CRA Trainee Program or 3 months of on-site monitoring experience; or equivalent combination of education, training and experience.
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