CRA - Medical Device

Highly Competitive
  1. Permanent
  2. Clinical Research Associate (CRA)
  3. Germany
Berlin
Posting date: 23 Jan 2019
CR.HB.21306_1548235537

ProClinical is happy to announce that an excellent CRA job opportunity has arisen for a CRA- Medical Device job to work with an orthopaedic and plastic surgery device distributor

As a Clinical Research Associate, the incumbent will work on remote and on-site monitoring of clinical research studies data within his/her assigned projects in the region covered by Clinical Affairs. This role will support projects primarily in Germany.

Job Responsibilities:

  • Assisting CAM/CAPM in protocol, and CRF designs and study documentation preparation.
  • Taking responsibility in activity for small projects.
  • Conducting on-site initiation visits, routine monitoring visits and closeout visits for both pre-and post - CE Mark studies.
  • Remotely monitoring and following up on queries with the Investigational centre(s) to address potential data discrepancies.
  • Maintaing appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
  • Evaluation the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Managing the process of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and data query generation and resolution.
  • Maintaining site performance metrics and implementing action plans for sites not meeting expectations.
  • Preparing and submitting regulatory packages to ethics committees and/or competent authorities.
  • Supporting the project manager in the development of monitoring tools, source document templates, CRF completion guidelines, Clinical Monitoring Plans.
  • Supporting EDC testing for newly implemented databased.
  • Mentoring Clinical Research Associates new to the company or position.

Skills and Requirements:

  • A bachelor's degree in science/health care field or nursing degree.
  • Minimum of 3 years of Clinical Research Associate experience.
  • Experience in the medical device industry.
  • Experience working with surgeons.
  • German native language and fluency in English.
  • An ability and willingness to travel 50% to 70% of the time, primarily via plane or train.
  • Advanced knowledge of CRA activities, essential for pre/post-market clinical studies.
  • Knowledge of applicable regulations (GCP, ISO-14155, MEDDEV guidelines, Data protection rules in EU).
  • Strong analytical and problem-solving skills, and flexibility to change.
  • Strong IT skills; including use of database programs for monitoring, analytics, and MS Office tools eg Excel and PowerPoint
  • Ability to manage multiple and varied tasks to meet deadlines
  • Excellent written and verbal communication and presentation skills

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Hermann Baer on +44 203 7520 316 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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