Clinical Research Associate *RUSSIA- Home based*

Employer
Docs Global (Continental Europe)
Location
RUSSIA
Salary
Competitive
Closing date
24 Sep 2020

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
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Role & Responsibilities:

Study Planning
• Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
• Assume ambassadorial role to facilitate communication between sites and Novartis CPO to increase value proposition to investigators.
• Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
• Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators. Ensure adherence to payment schedule.
Study Start-up
• Execute site initiation and training, generate initiation visit report.
Study Execution
• Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
• Identify problems at sites; resolve issues and escalate as appropriate.
• Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
• Complete preparation and generation of visit monitoring reports as per relevant SOP
• Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
• If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues
Study Close-out
• Implement site close-out activities and generate site close-out report.
• Provide feedback on site performance for future trial site feasibility/selection
General
• Improve skills by timely completion performance of assigned global and local training.

What is Required:

Education: BSN/BS/MS or BA required
Experience: a minimum of 2/3 years independent monitoring experience
TA: Oncology highly valued
Knowledge of Microsoft Office applications especially Excel
English: Fluent spoken & written
Good interpersonal skills demonstrated as proactive, enthusiastic, and independent thinker
Ability to collaborate and build strong relationships with all functions involved in the trial
Works and meets deadlines with some supervision
Must be able to travel in accordance with company and project requirements

What is Offered:

We offer a permanent contract, full time role based in Madrid or Barcelona
We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

#CRAjob

DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. 

 

Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business Park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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