Company: RBW Consulting
Reference: CRA den
Closing Date: 17 Dec 16
Type: Full Time
Salary (£): Competitive
Description We are currently looking for an experienced CRA in Denmark to join a world leading CRO in their exciting late phase team. The role will involve Real World Studies and you will be involved in all different areas as well as non-intervention studies. In this role you would also be a big part of the study start-ups in Denmark and therefore you will ideally have experience in this area as well. Home- based with minimal travel.
Real World, Late Phase CRA to Denmark
We are currently looking for an experienced CRA in Denmark to join a world leading CRO in their exciting late phase team. The role will involve Real World Studies and you will be involved in all different areas as well as non-intervention studies. In this role you would also be a big part of the study start-ups in Denmark and therefore you will ideally have experience in this area as well. Home- based with minimal travel.
You will conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
· Perform site selection, initiation, monitoring and close-out visits in agreement with contracted scope of work and good clinical practice.
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
· 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), Clinical Research Specialist (CRS) and/or line manager.
· Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
· Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
· Act as a mentor for clinical staff including conducting co-monitoring and training visits.
· May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes.
· In depth 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
· Strong written and verbal communication skills in both Danish and English
· Excellent organizational and problem-solving skills
· Effective time management skills
· Ability to manage competing priorities
· Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
We would like to see that you have a Bachelor's degree in a health care or other scientific discipline or educational equivalent and a minimum of 3 years of on-site monitoring experience; or equivalent combination of education, training and experience.
Primary Location > Denmark
Minimal Travel > 30-40%
Southdown House, 130a Western Road, Brighton BN1 2LA
|Tel:||01293 584 300|
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