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Clinical Research Associate, Germany - M

Employer
ClinChoice
Location
Germany
Salary
Competitive
Start date
19 Sep 2020
Closing date
19 Oct 2020

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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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    Company

    ClinChoice

    ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

     

    We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

     

    Company info
    Website
    Telephone
    +44 1628 566121
    Location
    Suite G48
    268 Bath Road
    Slough
    Berkshire
    SL1 4DX
    United Kingdom

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