The UCRC is a collaborative partnership formed in 2013 between the Ministry of Health and the Ministry of Higher Education of Mali, the University of Sciences, Techniques and Technologies of Bamako, Mali (USTTB), and the, National Institute of Allergy and Infectious Diseases (NIAID) of National Institutes of Health (NIH), Bethesda, Maryland.
This collaborative partnership aims to:
• Facilitate the development of a coordinated clinical research program in Mali
• Enhance the existing clinical research programs and facilitate their growth and sustainability
• Stimulate clinical research in West Africa that is guided by international standards and principles
• Develop an excellent research environment that will foster collaborations and attract researchers worldwide
As an integral member of the research team at the University Clinical Research Center (UCRC) and in compliance with all regulatory institutional and departmental requirements, the incumbent will be responsible for programmatic maintenance and support of studies. Reporting to respective Study Coordinator, specific responsibilities will include all regulatory support of protocols start prior and post-activation responsibilities and will serve as a liaison between the sponsor, CRO, IRB and internal departments/staff. It is expected that the Clinical Research Regulatory Specialist will dedicate 40 hours/week (5 day/week or 100% of full-time effort) for this position. The position will be based at the USTTB, UCRC, Bamako, Mali.
• Operational Support
o Provide support to in the implementation of the day to day operational plan of UCRC
o Promote UCRC values
Description of Responsibilities:
• Assist during protocol development to ensure regulatory and some operational needs are incorporated in the protocol.
• Aid in the development of specific standard operation procedures (SOP).
• Maintain current knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.
• Obtain initial and continuing approvals from various committees and organizations: Scientific Committee, Institutional Review Board, Biosafety Committee.
• Assist the research team with the development and implementation of amendments.
• Coordinate training on protocol prior to and, as needed during implementation.
• Assist in preparation for monitoring visits (initiation, interim and closeout) and related activities.
• Meet and correspond with sponsor and/or CROs during monitoring visits and ensure study regulatory files are up to date & audit ready.
• Assist study team with review of related regulatory aspects of monitoring findings and ensure prompt resolution and future prevention of such findings.
• Accurate preparation of annual renewals & study closure for IRB & sponsors.
• Submission of study amendments in a timely fashion including changes to the protocol, consent forms and other study documents.
• Liaise with Ethics Committee and other Regulatory authorities to ensure timely turnaround of review and approval of all the UCRC submissions.
• Maintenance of regulatory master files for industry & investigator initiated trials.
• Assist in developing and implementing protocol training and teaching tools.
• Develop and implement quality assurance procedures related to protocol adherence and data collection
• Monitor and provide guidance to ensure quality data
• Monitor and provide guidance related to SOPs to ensure human subject protection and safety
• Maintain expertise through familiarity of clinical research literature/other means
• Report on related quarterly and annual operational plan/activities
• Register study into clinicaltrial.gov
• Perform all other duties as assigned by supervisor
• Community relations/advocacy
• Communicate with stakeholders to keep them informed of the work of the organization
• Identify changes in the community served by the organization
• Establish good working relationships and collaborative arrangements with community groups, funders, researchers, politicians, and other organizations to help achieve the goals of the organization
REQUIRED SKILLSET / KNOWLEDGE BASE
• Knowledge of Microsoft software applications (Word/Power point/Excel) (in windows setting)
• Excellent communication skills
• Must be bilingual in French/English
• Ability to prepare power point presentations, executive written word document reports or other documents on behalf of the hierarchy
• Ability to prioritize multiple tasks/projects
• Ability to compile, analyze and track program/project information and data
• Ability to exercise good judgment in planning and accomplishing goals
Requirements for the Clinical Research Regulatory Specialist:
• 2+ years of experience managing and submitting regulatory documentation for clinical trials (IRB/GCP/FDA)
• Advanced knowledge of medical terminology
• Ability to perform duties in French and English preferred
• Working knowledge of database management programs, analytical tools, and CTMS, EDC, REDCap
• MD, PharmD, Ph.D. in science-related field preferred, Bachelor or Master’s Degree in medical training/health-related background acceptable
Required Information to be provided
• A cover letter
• A Curriculum Vitae details with evidence of experience
• A certified copy of diplomas
• Two letters of support from previous employers,
Application forms (paper version) shall be drop at the University Clinical Research Center (UCRC) USTTB- POINT -G- BAMAKO, MALI-BP-5445
In closed envelopes with the mention « Submission of application for the position of Clinical Research Regulatory Specialist »
or electronic should be send to: firstname.lastname@example.org
Deadline for application: July /15/ 2020 at 5 p.m.