Medical Monitor
Robarts Clinical Trials
București, Romania
2 zile în urmă

DEPARTMENT / UNIT SUMMARY :

Robarts Clinical Trials is a niche Clinical Research Organization that specializes in Inflammatory Bowel Diseases (IBD) research.

Based in London, Ontario (Canada), Amsterdam (The Netherlands) and San Diego, California (USA) Robarts has specific expertise in the design, implementation and interpretation of multicenter randomized controlled trials in both Crohn's disease and Ulcerative Colitis.

Currently Robarts is setting up 'translational expert centers' across the globe for early drug assessment in IBD. Besides protocol development and execution, Robarts' expertise is focused at pharmacokinetics, biomarkers, imaging and biostatistics in IBD.

JOB SUMMARY :

This role is intended to provide unbiased, 24 / 7, medical guidance to clinical sites and study operations teams. The medical monitor provides therapeutic and compound training, medical guidance on protocol compliance and coding of medical terms.

The medical monitor supports clinical safety and data management by reviewing data listings. The medical monitor may also assist with the writing of the final study report.

The medical monitor provides regular communication to the medical team (including medical teleconferences), and interfaces with sponsor Medical groups throughout the study.

AREAS OF RESPONSIBILITY :

Medical Oversight

  • Provide clarity on general protocol questions, and medical guidance for protocols as required.
  • Serve as medical expert providing guidance on patient eligibility matters, and investigational product related questions
  • Document contacts in accordance with Robarts or study specific procedures.
  • Consult with Robarts Medical Director(s), Sponsor Medical group and / or Safety with regard to medical questions pertaining to the indication under study.
  • Quickly identify safety issues as appropriate
  • Provide consultation on the unblinding of trial participants / site staff to subject treatment allocation
  • Review individual, out of range laboratory values following study-specific laboratory guidelines and alert values (as appropriate)
  • Review protocol deviation data and recommend protocol changes as appropriate
  • Follow a study-specific medical monitoring plan if applicable
  • Provide medical review of study level data, to identify gaps and areas requiring additional safety-related follow-up
  • Participate in the development, review and finalization of protocols, amendments, Clinical Study Reports, as required
  • Provide medical input into data collection tools, study plans (e.g., monitoring, statistical analysis plans, etc.
  • Provide medical input into study feasibility, site selection and site initiations as required
  • Attend and lead medical monitoring teleconferences at regularly scheduled intervals throughout the study, if required
  • Knowledge

  • Maintain a thorough working knowledge of protocol(s) and the current Investigator Brochure(s) with particular attention to those aspects relating to safety data involving human subjects
  • Training

  • Provide internal training to Robarts operational teams on specific diseases, drug targets, pharmacology, protocol requirements etc, as needed to support execution of client studies
  • Assist with the development of investigator training and meeting support materials.
  • Attend and present at investigator meetings and CRA training meetings.
  • QUALIFICATIONS :

    Applicants should have a minimum of a Medical Degree (MD) and 3-5 years of relevant experience with significant job-related training.

    Further, the successful candidate will possess strong written and verbal communication and presentation skills, enabling effective interactions with team members within Robarts, client company personnel and prospective sponsors.

    Advanced understanding of drug development process, ICH and Good Clinical Practices (GCP) is required.

    WORKING CONDITIONS :
  • Home-based
  • Home-based
  • Moderate Travel (international)
  • Accommodations for job applicants with disabilities are available upon request.
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