Across the globe, we keep our commitment to improve health and improve lives, and at Labcorp we are looking for exceptional people who are eager to play an important role pushing new frontiers in how we diagnose, monitor and treat patients in Medical Devices studies. This role will involve international monitoring visits across EMEA countries such as France, Germany, Greece, Netherlands, Spain, UK or Italy
The Clinical Research Associate is responsible for site monitoring and site management across multiple countries
. Responsibility for clinical studies according to Labcorp, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines.
- 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, as assigned
- Responsible for all aspects of site management as prescribed in the project plans General On-Site Monitoring Responsibilities:
- 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
- Ensure the resources of the Sponsor and Labcorp are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp travel policy
- Travel across EMEA will be required and is an essential function of the job
- Prepare accurate and timely trip reports
- Manage small projects under direction of a Project Manager/Director as assigned
- Undertake feasibility work when requested Conduct, report and follow-up on Quality Control (QC) visits when requested Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation and organization of meetings.
At Labcorp you'll experience :
- Career progression & learning: Labcorp works with a wide number of clients, you'll have the possibility to learn different ways of working and developing in your role.
- Where do you see yourself moving forward? Do you want to become an expert in a specific Therapeutic Area? Or to diversify your scientific knowledge? Or gaining expertise in a specific study phase (from I - IV)? We will support you to accommodate your career expectations.
Labcorp is proud to be an Equal Opportunity Employer:
- Unlike other CROs, there are not fixed boundaries between teams: we offer flexibility with great opportunity to grow into a variety of areas such as Project Management, Clinical Team Leadership, Line Management and cross border roles.
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
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