The World Bank is looking to hire a short-term consultant (STC) to:

  1. Support Biotechnology Industry Research Assistance Council (BIRAC) in evaluating the clinical trials at an operational / systems level by evaluating the processes of grantees:

BIRAC has already selected a few grantees developing products that will need to undergo clinical trials. It is expected that two to three grantees will apply for, receive regulatory approval, and/or start clinical trials by the first half of the 2019 calendar year.

For each clinical trial, the consultant will:

  • Prior to trial start, review and evaluate the sponsor/CRO’s standard operating procedures (SOPs) against best practices (e.g. criteria for selection of trial sites, criteria for selection of key personnel, adequacy of team, etc.) and provide BIRAC with an assessment of the adequacy of the sponsor/CRO’s systems.
  • For trials in implementation phase, familiarize themselves with the Essential Trial Documents (ETDs) - such as protocol of the proposed research, informed consent process, Compensation provisions, etc. - and evaluate the trial’s compliance with SOPs and ETDs.

To conduct this work, the consultant is expected to visit the sponsor/CRO for each clinical trial at least twice (one visit for each stage above). 

  1. Evaluate on behalf of the World Bank Team the project’s compliance with the Clinical Research and Validation Management Framework (CRVMF) agreed upon as part of the implementation arrangements of the project.

While the CRVMF builds on standard legal and regulatory framework for clinical trials in India, which are not under the purview of BIRAC but rather under that of the appropriate regulatory authorities, it also establishes requirements for i) BIRAC oversight for clinical trial management ii) a program-based grievance redressal mechanism and iii) capacity building and technical assistance relating to the CRVMF.

The consultant will:

  • Assess existing mechanisms at BIRAC for compliance with the CRVMF.
  • Provide recommendations to improve system’s compliance with the CRVMF

DELIVERABLES

  1. support BIRAC in evaluating the clinical trials at an operational / systems level

The deliverables will be i) and initial report assessing the sponsor/CRO’s systems and highlighting any gaps to be addressed; ii) For clinical trials in the implementation phase, a follow up report assessing the trials’ compliance with SOPs and ETDs during implementation

  1. Evaluate the project’s compliance with the Clinical Research and Validation Management Framework (CRVMF)

The deliverable will be a report assessing existing mechanisms for compliance with the CRVMF, highlighting gaps, if any, and providing recommendations for improvement.

SELECTION CRITERIA

The ideal candidate will have the following qualifications:

  • Expertise in biomedical ethics, with at least ten years of work experience in biomedical ethics, biomedical research, or clinical trials management and knowledge of Good clinical practices
  • Strong analytical and written communication skills
  • High proficiency in English
  • Experience working in India and  knowledge of Indian GCP and regulatory approval system is a plus

TIMING, LEVEL OF EFFORT, AND ACCOUNTABILITY

The STC will be hired for a period of (30) days beginning January 1st, 2019 and ending June 30th, 2019, to be extended as needed, contingent on acceptable performance and after agreement by both parties.

The Consultant will work both on and offsite with a minimum of two visits to India over the period (an initial 10-days mission is envisaged in first half of January).

The consultant will report to the World Bank and work closely with the BIRAC team.

Fees will be commensurate with experience and qualifications as per WBG rules.

For further information, please contact Robert Oelrichs - email: roelrichs@worldbank.org