WHAT YOU’LL DO
The Clinical Research Associate II will take part in all areas of clinical trial management in Europe. This includes, but is not limited to, day-to-day activities such as trial start-up, conduct, and closeout activities as well as supporting a range of activities on large multi-center studies, management of vendors and management of investigative sites with the support of Endotronix Director of Clinical Operations. Although this is a remote position, you must be located in Ireland, Germany or The Netherlands. Your responsibilities will include:
- Participate in the management of the completion of routine trial start-up, conduct, and close-out activities to industry and corporate standards, with support from the Director of Clinical Operations
- Evaluate and select investigative sites
- Site monitoring responsibilities for Clinical trials, according to Endotronix Standard Operating Procedures, ISO, ICH and GCP Guidelines, including Pre-study, Site Initiation, Routine Monitoring and Close-out visits.
- Manage some aspects of trial operations including internal metrics, and communication of trial status within and outside the trial team
- Ensure that assigned clinical trial tasks are conducted in accordance with the protocol, country regulations, Good Clinical Practice regulations, ISO 14155 and internal Standard Operating Procedures
- Follow up and implement clinical site contracts and budgets
- Involvement in various tasks to support the Study Team/Management with any trial related activities in all phases of the conduct of the clinical trial
- Prepare study specific tools (including communication tools such as newsletters, flyers etc.)
- Manage trial specific TMF (setup, maintain, archival) including, as/if appropriate, site regulatory document and legal document tracking and archiving throughout the duration of the clinical trial in accordance with SOPs, ISO 14155, GCP and ICH guidelines
- Manage all study-related supplies
- Assist with the writing and review of clinical documents such as informed consents, trial reports, and annual reports
- Assist with the organization and participate in investigational meetings and site training representing assigned clinical trial
- Perform co-monitoring visits as required
WHAT YOU BRING TO THE TABLE
- 2+ years’ experience as a CRA in Medical Device and/or Cardiology Trial
- Familiarity with clinical research in Cardiology
- Familiarity with Medical Device regulations of clinical trials
- Understanding of the EU legislation governing clinical trials and GCP
- Ability to maintain excellent working relationships with a broad range of trial staff
- Must be highly motivated, have excellent interpersonal and written communication skills, great desire to help others, composed under stress and well organized
- Strong critical thinking and problem-solving skills
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
- Excellent organizational and record-keeping skills
- Ability to work well in a team environment but also independently on assigned tasks without significant oversight
- Detail and process oriented
- Positive attitude and approach
- Computer proficiency (MS Office – Word, Excel, Power Point and Internet skills}, aptitude for training
- Must be willing and able to travel
- Fluency in English (both spoken and written) is essential for this position.
EDUCATION
- Bachelor’s Degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).
More Information
- Experience Level Junior
- Total Years Experience 0-5
- Radio field Option 1
- Dropdown field Option 2
- Multiple Select field Option 3
- Checkbox field Option 2
