Clinical Research Associate, Germany - S

Employer
CROMSOURCE
Location
Germany
Salary
Competitive
Closing date
20 Sep 2020

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
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Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a CRA to join one of our clients as a perm member of their team (not a contractor). The successful candidate will join a fast-paced, dynamic team within our client and the individual will play a pivotal role in the implementation of new therapies.

This is for one of the leading global Medical Device companies and is global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring.

Responsible for remotely supporting field clinical research associate/ site activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sites.

Key Responsibilities:

Organising and supervising clinical study
  • Assist and conduct Clinical Monitoring activities
  • Serve as key contact to assigned clinical sites throughout the study process
  • Is accountable for achieving and reporting on agreed clinical milestones
  • Supports study team in the interactions with Ethics Committees and Competent Authorities
  • Participates actively to project team meetings, as required
  • Close collaboration with internal stakeholders to ensure proper project conduct
  • Assist in Providing site and Edwards personnel training including preparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required
  • Reporting site enrolment progress including device accountability and protocol deviations (inclusion/exclusion criteria, sequential enrolment) 6. Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation
  • Processing adverse events
    • Document procedural case observations for insights in investigating post procedural events
    • Data review, safety reporting and complaint handling
    • Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements
    • Identifies and supports process improvement opportunities and implementation
    • Ensures Audit readiness for internal, external and site Audits
  • Education and Experience:
    • Bachelor's Degree or equivalent in in related field
    • 1 year experience of previous related medical device and/or clinical experience required
    • Other: Clinician experience in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) Preferred
    • Other: Experience in interventional cardiology or cardiothoracic surgery preferred
  • Additional Skills:
    • Good computer skills in MS Office Suite and ability to operate general office machinery
    • Good written and verbal communication skills, presentation and interpersonal relationship skills
    • Good problem-solving and critical thinking skills


    Compensation program, includes competitive salaries, performance-based incentives, stock options, and retirement plan options:

    Pay: Includes competitive Base Pay and additional Variable Pay based on the performance of the company and/or you

    Stock: The opportunity to purchase stock at a discount through the Employee Stock Purchase Plan

    401(k) Savings & Investment Plan: Includes matching contributions from company

    Health and well-being: Includes health, life and disability insurance, Total Wellness program, paid time off and family leave

    The Application Process

    Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

    If you would like to discuss the role before applying through the website @

    or please contact Alexander.Sourounis@cromsource.com for more information.

    Keywords: Clinical Research Associate
    Skills: Medical Devices, Monitoring Location: Germany Share:

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    CROMSOURCE is an ISO-certified international provider of fully outsourced services to the pharmaceutical, biotechnology and medical device industries, specialised in clinical development and flexible resourcing solutions. CROMSOURCE was founded in 1997 and its successful growth has been built on stability, integrity, and high levels of customer satisfaction. We have grown steadily through offices across all regions of Europe and North America and delivering a comprehensive breadth of services.

    Acting through PharmaceuticalMedical Device and Flexible Resourcing Solutions teams, and with a comprehensive portfolio of services, we offer a flexible approach to ensure CROMSOURCE optimally supports the unique needs of each client. This could mean providing regulatory consultancy to a small company at the early stages of a medical device development programme, through to provision of full services to a pharmaceutical company performing an international mega-trial to support registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high quality service within budget and to timelines agreed.

    We are experts providing experts and we live by our motto – Advise Agree Deliver. This means we leverage our experience and expertise at the early stages of discussions with our clients to freely advise them on the optimal project plan. We then reach agreement with each client on the scope of service, timelines and budget. CROMSOURCE then commit to deliver those services on time and within budget – according to our End-to-End Guarantee and this commitment to guaranteed delivery is unique in the clinical research environment.

    Contact Us
    • 6-9 The Square
    • Stockley Park
    • Hayes
    • UB11 1FW
    • United Kingdom
    • +44 (0) 1786 468990
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