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Clinical Research Facilities (Crf) Study Manager At International Livestock Research Institute (Ilri)

Expertworld Concepts

Manufacturing / Production / FMCG full time Nairobi Posted 16 hours ago

The International Livestock Research Institute (ILRI) works to improve food security and reduce poverty in developing countries through research for better and more sustainable use of livestock. ILRI is a CGIAR research centre - part of a global research partnership for a food-secure future.Key Responsibilities: Investigator Serve as Investigator as needed on studies as appointed by Test Facility Management Primary role in drafting study protocols and budget development; protocol development, writing, editing and review; study report writing, editing, and review Drafting and submission of research approvals to IACUC and IBC, including addressing any questions received from these committees; Obtaining all necessary approvals from national and international authorities (NBA, NACOSTI, DVS, NEMA etc) Ensure the health and welfare of the personnel involved in the study and the animals during the study through monitoring adherence to the Biosafety Manual and animal welfare policies Overseeing the receipt, dispensing, and disposal of investigational veterinary products according to the study protocol, local regulations, and internal standard operating procedures Overseeing the receipt, dispensing, and disposal of imported biological material according to the import permit and protocol requirements Manage & oversee study phases outsourced to approved external laboratories / consultants / vendors Provide guidance and training on studies to research and technical staff Study sponsor interaction and effective and timely communication to study sponsor representatives, study monitors and site management on study progress and results, including addressing any study related questions Coordinate and/or participate in day-to-day research activities such as dose preparation, administration, observations, sample collection and other related research tasks Assistant study Investigator Serve as lead support to a Investigator as needed on studies as appointed by Test Facility Management Study master file administration, including, but not limited to the preparation and close-out of files, raw data reviews, and data management tasks Assist in drafting study proposals, protocols, and reports Assist in drafting research approval applications to IACUC and IBC Coordinate study related activities with other applicable departments as necessary Coordinate and/or perform study setup: preparation and review of facility/study logs, study rooms/cages, animal selection and acclimation, environmental enrichment, scheduling study activities, and other related duties as needed Coordinate and/or participate in day-to-day research activities such as dose preparation, administration, observations, sample collection, and other related research tasks Communicate study progress to the Investigator and Study Sponsor when requested Timely reporting of study adverse events to the Investigator General Team Lead duties which include resource scheduling and updating of departmental worksheets in line with good people practices and in accordance with departmental objectives Coordinate and/or respond to QA, regulatory agency, and sponsor audits in a timely manner Develop, validate, and execute novel study models Identify and implement preventative measures in accordance with set instructions and procedures in cases where serious diseases are suspected Control document development and review as required Perform any other related duties as may be required Requirements Masters degree  in Natural or Biological Sciences with 7 years of experience Expertise in animal health, animal welfare, biosecurity, bio-safety and the 3Rs (Refine, Replace and Reduce) concept associated with animal health research. Knowledge of VICH GL9 (GCP) Expericne with qPCR and immune assays (ELISA, IFN-y ELISpot and VINT) would be an added  advantage. Ability work in multi-cultural environment and foster teamwork Ability to work the limited supervision and to take initiatives.