Scope – Measles Study Clinician Guinea Research Program

2023-10-04 15:23:03

Partnership for clinical research in Guinea: Scope – Measles Study Clinician Guinea Research Program

The “Partnership for Clinical Research in” (PREGUI) is a collaborative partnership between the Ministry of Health of Guinea and the National Institute of Allergies and Infectious Diseases of the United States National Institutes of Health.

This collaborative partnership aims to
• Facilitate the development of a coordinated clinical research program in Guinea
• Improve existing clinical research programs and facilitate their growth and sustainability
• Stimulate clinical research in West Africa based on international standards and principles
• Develop an excellent research environment that will foster collaborations and attract researchers from around the world.

The PREGUI partnership supports the measles study for. .The Clinician provides support for the technical management of PREGUI programs.
The Clinician is expected to devote approximately 40 hours per week (5 days per week or 100% of their full time) to this position. The position will be based at the Maferinyah Research and Training Center, Guinea and will report to the Director of PREGUI.

Main responsibilities:

Scientific and technical responsibilities
• Protect the rights and well-being of human beings participating in research. The clinician must place the rights, well-being, and safety of the participant above all other personal and scientific matters.
• Obtain informed consent from subjects (if necessary) before they participate in research by:
o Providing oral information as adapted as possible to the person requested, avoiding any direct or indirect pressure and ensuring that the subject has understood the project.
o Granting the patient reasonable time for reflection depending on the situation.
o Give the participant a copy of the informed consent duly completed and signed by all parties.

• Know and understand the ethical standards and regulatory obligations governing research activities involving human beings.
• Implement the research project in accordance with
o the conditions issued by the Ethics Committee, upon approval of the project (provide the clinical trial agreement signed by the different parties for the protocols, provide the insurance certificate when the legal sponsor is the institution).
o Implement the protocol validated and approved by the Ethics Committee and in accordance with national and international regulations.
• Keep written records of the analyzes and decisions of the ethics committee and keep written evidence of the informed consent of participants or their authorized legal representative.
• Ensure the confidentiality and security of all information obtained from and concerning participants, in accordance with the recommendations issued by the ethics committee and in accordance with national and international regulations.
• Ensure adequate conditions for conservation of samples and study archives.
• Participate in the continuing training of research staff (co-investigators and clinical research assistants) on the rules governing research and the institution’s research policies.
• Participate in the supervision and monitoring of the study.
• Prepare the declaration and detailed report of adverse events.
• Obtain approval from the ethics committee for any proposed modification of the research protocol initially submitted before its implementation.
• Submit to the requests of the ethics committee by declaring in due time:
o The effective date of start of the study (first selection/first inclusion).
o The reasons why the launch of the project is postponed, if applicable.
o Any unforeseen problems presenting risks to subjects or others, including the measures taken to remedy them.
o Serious adverse events occurring locally in relation to the measures taken to remedy them, including the formalities initiated so that the participant can benefit from damage coverage by the study insurance, if applicable.
• Ensure the transfer of information and data collected for the study in the observation notebook (Case Report Form: CREF) in a clear, readable manner and in line with the source documents (participant file).
• Obtain authorization from the Ethics Committee to continue the study by providing a progress report on the study on site according to the schedule prescribed by the Ethics Committee (annual report most often, semi-annual report for studies having requested the benefit of emergency, cohort report for phase I trials).
• Inform the ethics committee of the closure of the study and provide an end-of-study report.

Other responsibilities
• Perform other tasks as assigned

Formation et experience
• Trained doctor
• At least 3 years of experience in the field of clinical research

Knowledge, skills and abilities
• Know and understand the ethical standards and regulatory obligations governing research activities involving human beings.
• Be able to work in a collaborative environment, propose ideas to management and work to achieve established goals and objectives in areas of clinical research.
• Possess strong management and organizational skills, and be able to prioritize multiple scientific research tasks/projects simultaneously.
• Demonstrate excellent written and oral communication skills.
• Knowledge of Microsoft software applications (including Word/PowerPoint/Excel).
• Ability to prepare high-level presentations and written reports.
• Ability to make sound technical and procedural decisions.

Submission of Application:
• Application files must be sent electronically no later than Wednesday October 11, 2023 by email to the following address: [e-mail]
• Application files must include a cover letter, CV and copy of diplomas.