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Experienced CRA - Multi-sponsor

Employer
Labcorp
Location
Athens, Greece
Salary
Competitive
Start date
22 Sep 2021
Closing date
27 Sep 2021

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Job Details


As a leading contract research organization (CRO), Labcorp Drug Development (formerly known as Covance) provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

THE JOB

We are currently searching for an experienced CRAto join our team in Greece. You will be part of our multi-sponsor structure and work with multiple sponsors, drive and coordinate activities across a range of stakeholders. In this role, you will have a permanent, full-time and home-based contract.

Essential Duties and Responsibilities:

- Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties
- Responsible for all aspects of site management as prescribed in the project plans
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
- Monitor data for missing or implausible data
- Ensure audit readiness at the site level
- Prepare accurate and timely trip reports
- Interact with internal work groups to evaluate needs, resources and timelines
- Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
- Responsible for all aspects of registry management as prescribed in the project plans
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
- Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
- Assist with training, mentoring and development of new employees, e.g. co-monitoring

Education/Qualifications:
We are searching for a university graduate with a life science degree, who relishes working in a fast paced environment, on complex and demanding protocols.

If you are someone who is eager to constantly develop and improve while working in a friendly and collaborative team environment; then we are looking forward to meeting you.
Experience:
- 1+ year of independent monitoring experience, gained at an international/regional CRO or global pharma company
- Basic understanding of Regulatory Guidelines
- Ability to work within a project team
- Good planning, organization and problem solving skills
- Works efficiently and effectively in a matrix environment
- Valid Driver's License

- Fluent in Greek and English

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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