Senior Clinical Research Associate - Netherlands

Highly Competitive
  1. Permanent
  2. Clinical Research Associate (CRA)
  3. Netherlands
Amsterdam, North Holland
Posting date: 10 Jun 2019
CR.RI.23789_1560160974

A leading biotechnology company is seeking to recruit a Senior Clinical Research Associate to their office in the Netherlands. This organisation supports the discovery, development, clinical trial work, and implementation of biomarkers essential for targeting patients more precisely and effectively. This is an exciting opportunity to work with an establishment that provides an uncommon array of talent and services to enable pharmaceutical and life sciences clients to take advantage of new advances in science. This position will be in a home-based capacity.

Job Responsibilities:

  • Serving as a member of the project team with the goal to contribute towards efficient management of trials.
  • Assisting the team managers in the preparation and review of protocols and other study documentation.
  • Designing and developing CRF and clinical trial document developments as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.).
  • Overseeing all aspects of study site management to ensure quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
  • Establishing, updates, tracks and maintains study specific trial management tools/systems, and status reports.
  • Managing site start up procedures, including the recruitment of potential investigators, preparation of EC/IRB submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings, and other tasks as instructed by the project manager.
  • Negotiating study budgets and assisting with the execution of investigator contracts.
  • Conducting all forms of monitoring visits, including pre-study, initiation, routine, and final monitoring visits, in accordance with the protocol, local laws, ICH-GCP, and Precision Oncology's SOPs.
  • Preparing accurate and timely visit reports from all monitoring visits.
  • Communicating effectively with both site personnel and Precision Oncology management to relay protocol/study issues, including any deviations, and implementing necessary actions in response to those issues.
  • Maintaining study tracking in accordance with the demands of the study.
  • Performing data management activities, including in-house CRF reviews, querying resolutions, and resolving data discrepancies, dependent upon the study/sponsor arrangement.
  • Identifying and processing Serious Adverse Events according to the procedures defined by the study team.
  • Demonstrating a full understanding of the SAE reporting process and when required, writing narratives and following-up on SAEs as needed.
  • Travelling as necessary according to project needs.
  • Functioning as a mentor, assisting with the training and developing of new employees and junior monitors.
  • Assisting with the development of SOPs.
  • Assisting with the review of clinical study reports.
  • Conducting feasibility work when requested.
  • Interacting with clients, participating in proposal activities, including development and client presentations.
  • Initiating payment requests for investigators.
  • Assuming project management responsibility as needed.
  • Performing other duties as assigned by management.

Skills and Requirements:

  • Graduate, postgraduate, 4-year college degree, or equivalent experience, ideally in a scientific or healthcare discipline.
  • 3 years or more as a CRA either in CRO or Pharmaceutical industry.
  • Demonstrates mastery knowledge of ICH-GCP, relevant Precision Oncology's SOPs, and regulatory guidance, as well as the ability to implement.
  • Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
  • Possesses basic understanding of financial management.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 contact Reem Iskandarani at +44 203 854 2629 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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