Remote Monitoring Associate (CRA) Ukraine
Job title: Remote Monitoring Associate (CRA) Ukraine
Job description: Remote Monitoring Associate (CRA) Ukraine
Ref #: 29320
Employment type: Permanent – Full-Time
As a Remote Monitoring Associate you will coordinate all aspects of the remote clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures.
You will be managing competing priorities, supporting the CRAs and on-site team, ensuring investigators follow the clinical trial protocol, providing training, and most importantly, motivating the team to ensure high quality results.
These positions are home based and don’t require traveling to clinical sites.
– Collaborate with CRAa on site issues/actions
– Perform regular reviews of data according to data review/monitoring guidelines (CTMS, ISF, EDC, IVRS, ISIS)
– Conduct remote visits (initiation, monitoring, termination)
– Primary in-house site support
– Create and distribute study document (e.g. eSignature Agreement, Amendments, etc.)
– Responsible for the completeness and quality of the in-house site specific files
– Update all relevant tracking system on an ongoing basis
– Maintain site staff details
– On a regular basis conduct outbound and receive inbound calls to:
○ Review recruitment plan and enrolment updates
○ address/resolve issues pending from the previous visit
○ address protocol questions
○ check on site staff assignment
○ assess drug/study supply status
○ request outstanding documents=
○ follow-up on data entry, query status and SAEs
○ follow-up on appropriate site related questions
○ build relationships with investigators and site staff remotely
Required experience and qualifications:
- Bachelor’s Degree (or equivalent), degree in Life Sciences, Clinical Research, Nursing or Pharmaceutical Sciences
- Previous on-site/remote monitoring experience or completed CRA training/CRA Academy
- Fluent English
- Prior clinical, data management and/ or research experience with understanding of clinical trials methodology and terminology
- Ability to learn quickly, communicate effectively
- Experience conducting all types of MVs such as: Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site would be a plus
- Organized, have strong attention to detail
- A demonstrated working knowledge of ICH/GCP Guidelines
- Excellent record-keeping skills and attention to detail
Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.
Job date: Sun, 23 May 2021 00:58:28 GMT
Apply for the job now!
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