USP seeks a Good Clinical Trials (GCP) Consultant for a potential 3-year project in DRC, where USP will provide assistance towards strengthening the maturity level of the National Pharmaceutical Regulatory Authority (ACOREP), strengthening capacities of the National Quality Control Laboratory, and developing strategy to strengthen local production of medicines and vaccines. The Good Clinical Trials (GCP) consultant will support USP by strengthening the capacity of ACOREP staff on key regulatory functions. Specifically, this includes providing clinical trials oversight including developing/updating the regulatory framework, guidelines, procedures, and processes that meet international standards in line with the WHO GBT requirements.
**This opportunity is connected to a proposal. Any consultant engagement is contingent upon contract award.**
Roles and Responsibilities
Potential tasks that the consultant/vendor will be responsible for carrying out include:
· Working with relevant legal experts, support ACOREP to review and update the regulatory framework including legal provisions, regulations, policies and guidelines for clinical trials oversight by the NRA in line with international standards and good clinical practices (GCP)[List]
· Support ACOREP to define the organizational structure for clinical trials oversight including monitoring, inspecting and auditing, with the roles and responsibilities for all relevant regulatory entities involved, and the communication and coordination mechanisms agreed and clearly documented.
· Work with ACOREP to draft/revise job descriptions for staff involved in clinical trials, utilize the WHO Competency framework or similar guidance documents to understand the training needs of staff, develop a training plan to bridge the gap and support delivery of training and capacity building initiatives for relevant clinical trials staff
· Support the drafting of relevant procedures (guidelines, standard operating procedures, reporting templates, checklists) for providing clinical trials oversight, including reviewing clinical trials applications, protocols and amendments, monitoring, inspecting and auditing clinical trials, communicating and sharing results of clinical trials review process with relevant stakeholders according to international standards and best practices
· Support the use of a risk-based approach for implementing activities related to the clinical trials oversight including analysis and reporting of clinical trials data, metrics and trends
· Support efforts to finalize the establishment and functioning of a clinical trials review committee defining its roles and responsibilities, and membership composition according to the needs of the country
· Contribute in efforts to enhance the use of regional reliance in clinical trials oversight such as participation in AVAREF
· Support ACOREP to establish a system to periodically monitor the performance of the relevant entities in effectively overseeing the clinical trial function. This will entail defining performance indicators in accordance with the WHO GBT.
· Support implementation of any other activity (as may be needed) for DRC to attain WHO maturity level 3 on the clinical trials function.
Qualifications
· A university degree (minimum 5 years of higher education) in pharmaceutical sciences, medicine, clinical research, public health, life sciences or related fields.
· At least 7 years of demonstrated international experience in conducting clinical trials or supporting, reviewing, inspecting or auditing clinical trials at the NRA, industry, contract research organization (CRO), clinical trial sites or an international health organization level to ensure compliance with good clinical practices (GCP).
· At least five years of demonstrated experience in supporting national regulatory authorities to strengthen their regulatory functions with emphasis on building capacity for clinical trials oversight.
· Proven experience in training regulators, clinicians, clinical trial review committee members, CROs, and other implementers on key aspects of conducting and monitoring clinical trials in line with GCP.
· Resides in the Africa Region (please list countries experience)
· Experience in clinical trial monitoring, including conducting audits/inspections in accordance with these good practices and supervising other auditors/inspectors.
· Experience in bioequivalence studies.
Preferred Qualifications
· Strong knowledge of ICH-GCP, WHO guidelines and regulatory science
· Experience in building institutional and individual capacity in the LMIC context including use of the WHO GBT to assess and strengthen NRA capacity
· Experience working with the pharmaceutical industry, contract research organizations, NRA or clinical trials site is highly desirable
· Excellent analytical, writing and communication skills and ability to work collaboratively with diverse stakeholders
· Proficiency in data analysis and regulatory information systems is an added advantage
· Fluency in both English and French languages is highly desirable
Application Procedure Please send your CV, Cover Letter, 3 References, and hourly rate (in USD) to GPH_Procurement@USP.org, by the closing date of October 24, 2025. When submitting your applications, please write “Clinical Trials (GCP) (Africa Region)” in the email Subject Line of your email.
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. USP’s Global Health programs have reached more than 90 countries across Africa, Asia, and North and South America to strengthen global supply chains and pharmaceutical ecosystems that enable a resilient supply of quality medical products.
