Clinical Trials Medical Consultant (NIH)

Position Overview

• Duty Location: Bethesda, Maryland
• Position Information: Part-time, On-site
• Vacancies: One Opening
• Travel Required: Occasional travel for meetings
• Relocation Expenses: No relocation expenses may be authorized for this position

Background

Ripple Effect works with federal, private, and non-profit clients to support some of the most crucial policies and programs that shape our nation. We provide professional consulting services in the areas of: Communications & Outreach; Program Management & Policy; and Research & Evaluation. Ripple Effect is an interdisciplinary environment, full of insightful and intentional people who value and reward adaptability, lifelong learning, and authenticity. To learn more about working at Ripple Effect and our growing team, check out the Future Ripplersection of our website.

Position Description

The Clinical Trials Medical Consultant (NIH) will be responsible for identifying, developing, leading, and conducting clinical program management efforts for Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Division of Extramural Research (DER). The Medical Consultant will review and evaluate information relevant to the management and oversight of clinical trials or other clinical studies in order to ensure compliance with NIH and NICHD policies and procedures, as well as the safety of human subjects throughout the development and implementation of the protocol. Protocols will be developed and supported by NICHD through different funding mechanisms and NICHD may or may not be directly involved in conduct of the trial, but plays an important role as the research funder.

Specific Duties may include:

• Serve as expert consultant to the DER Director, senior DER leadership, and NICHD program staff on clinical, ethical, policy, and regulatory issues related to the extramural clinical research portfolio
• Assist NICHD staff with coordination, oversight, and guidance on areas described above, as well as other areas such as data sharing and certificates of confidentiality
• Provide expert input regarding clinical trial/clinical research operations and procedures to NICHD staff who oversee networks or other cooperative agreements or contracts, as needed

• Provide expert input, as needed, to the Program Officer on individual study medical monitoring plans and milestones

• Provide expert consultation on clinical trial operations and procedures to Program Officer, Project Scientist, and/or DCC (data coordinating center)/clinical site investigators
• Assist DER staff by providing clinical and regulatory advice and guidance on the extramural clinical research portfolio

• Other potential duties as needed:
  • Review reports on subject safety, protocol and regulatory compliance, and data accuracy
  • Provide expert consultation to NICHD staff on safety issues for protocols funded on NICHD networks or other cooperative agreements or contracts

• At the direction of NICHD staff, provide expert input to the network investigator team on clinical development plans, protocol designs, and risk assessments, if needed

• Provide input to NICHD staff in the review of clinical and medical data in reports of adverse events, protocol deviations, and unanticipated problems

• Review investigator brochure

• May assist with regulatory agency support, as needed