Medical Research Specialist

6 days ago


Bengaluru, Karnataka, India George Clinical Full time
About the Role

The Medical Monitor is a key member of our team, responsible for providing medical and academic input to various aspects of our clinical trials. This includes ensuring project delivery is of high quality, operationally aligned, cost-effective, and competitive. The Medical Monitor will work closely with cross-functional teams to make decisions and provide medical input to safety and endpoints documents, project plans, and other relevant documents.

Key Accountabilities
  • Provide medical and academic expertise for new and existing clinical trials.
  • Support Endpoint Adjudication and other relevant Committees where required.
  • Provide medical input to safety and endpoints documents and to project plans and documents as required.
  • Represent George Clinical and its values with academic colleagues, commercial customers, vendors, government, and regulatory bodies as requested.
  • Participate in team meetings and activities as required.
  • Ensure activities comply with relevant Acts, legal demands, and ethical standards.
Project Development, Initiation, and Support

The Medical Monitor will provide clinical input into the development and/or review of study protocols, procedure manuals, data collection tools, and data quality plans. This includes reviewing query reports generated from project databases to identify errors and inconsistencies, as outlined in the medical monitoring plan. The Medical Monitor will also provide ongoing, continuous support to sites by taking and answering queries related to medical issues around patient eligibility, recruitment, treatment, and management, and adverse events, etc. as outlined in the scope of the medical monitoring plan.

Endpoint Adjudication Activities

The Medical Monitor will liaise with project teams, data management, endpoint coordinators, investigators, site staff, sponsors, and endpoint adjudicators as needed. This includes providing clinical input into the development of endpoint adjudication manuals, plans, charters, tracking tools, and associated documentation. The Medical Monitor will also provide medical review and input to endpoint packages as required.

Safety Activities

The Medical Monitor will liaise with internal and external stakeholders as appropriate. This includes providing clinical input to the development of safety manuals, plans, charters, tracking tools, and associated documentation. Where contracted, the Medical Monitor will review and provide narratives for Serious Adverse Events reported on George Clinical trials according to timelines described in the project plans. The Medical Monitor will also provide medical advice and guidance for George Clinical Safety team.

Requirements
  • Tertiary qualifications in medicine.
  • Experience and expertise in clinical research.
  • Understanding of academic research.
  • Working knowledge of current ICH/GCP, ethical, and regulatory requirements.
  • Highly developed interpersonal, relationship-building, and negotiation skills.
  • Excellent communication skills including verbal, written, and presentation skills.
  • Ability to travel domestically and internationally.
  • Technological proficiency including Microsoft Office packages.
  • Ability to see the big picture, yet still focus on detail and quality of work.
  • Ability to be flexible and adaptable in changing organizational priorities and ambiguous environments.


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