Medical Monitor

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Emmes Services Pvt. Ltd , ("Emmes") is searching for Medical Monitor in Clinical Research located in our Bangalore, India office. Emmes provides flexibility for office location preference, dependent upon position.

EMMES Services Pvt. Ltd, Bangalore, a fully owned subsidiary of The Emmes Company, LLC. Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

The Safety Monitor is responsible for coordinating the safety aspects of the project with the medical monitor and the project team.

Responsibilities
  • Collaborates with clinical investigators to determine study design.
  • Provides safety review and first line evaluation of serious adverse events (SAEs).
  • Maintains ongoing database of SAEs.
  • Maintains a summary narrative for each reported SAE suitable for inclusion in DSMB reports , regulatory submissions and final study reports.
  • Reconciles SAEs in the database as needed.
  • Communicates with Emmes and/or site staff regarding reported AEs or SAEs to gather additional information.
  • Submit applicable documentation to regulatory authorities such as DCGI and Ethics committee regarding adverse events.
  • Responds to site and client requests for information regarding safety in clinical trials.
  • Reviews and contributes to Data Safety Monitoring Committee/Board reports regarding safety; review and contribute to safety sections of annual reports, and periodic safety reports.
  • Participates in DSMB and other safety review meetings.
  • Participates in the planning and preparation of the adverse event section of protocols for studies
  • Collaborates with Protocol Monitor to assure site compliance and understanding of all safety reporting requirements.
  • Participates in Clinical Team meetings and similar meetings representing Safety Department.
  • Provides adverse event and clinical trial expertise to training effort.
  • Performs MedDRA coding for Adverse Events.
  • Performs WHO drug coding for concomitant medications.
  • Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT), project SOP and Compliance/Variance table development, participation of internal and external audits, and professional development activities.
  • Demonstrates understanding of project and corporate SOPs by producing work in compliance with the SOPs. Maintains documentation required by corporate and project SOPs.
  • Contributes to drafting and review of corporate SOPs related to safety.


Experience

  • Requires medical training including an MD/MBBS degree, RN degree, or a physician assistant degree, or equivalent.
  • Experience in clinical trials research with 2-4 years' experience in safety/pharmacovigilance preferred.
  • Excellent knowledge of medical terminology and ability to extract information to create a case history.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Thorough knowledge of regional and international regulations pertaining to pre-marketing and post marketing safety and surveillance.
  • Working knowledge of MedDRA dictionary with relevance to adverse event analysis and adverse event coding.
  • Working knowledge of WHO drug dictionary with relevance to concomitant medication analysis and coding.

Excellent oral and written communication skills.

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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