Clinical Research Facilities (CRF) Study Manager

ABOUT THE COMPANY

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.

JOB SUMMARY

RequirementsMasters degree  in Natural or Biological Sciences with 7 years of experienceExpertise 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 teamworkAbility to work the limited supervision and to take initiatives.

RESPONSIBILITIES

InvestigatorServe as Investigator as needed on studies as appointed by Test Facility ManagementPrimary role in drafting study protocols and budget development; protocol development, writing, editing and review; study report writing, editing, and reviewDrafting 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 policiesOverseeing the receipt, dispensing, and disposal of investigational veterinary products according to the study protocol, local regulations, and internal standard operating proceduresOverseeing the receipt, dispensing, and disposal of imported biological material according to the import permit and protocol requirementsManage & oversee study phases outsourced to approved external laboratories / consultants / vendorsProvide guidance and training on studies to research and technical staffStudy 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 questionsCoordinate and/or participate in day-to-day research activities such as dose preparation, administration, observations, sample collection and other related research tasksAssistant study InvestigatorServe as lead support to a Investigator as needed on studies as appointed by Test Facility ManagementStudy master file administration, including, but not limited to the preparation and close-out of files, raw data reviews, and data management tasksAssist in drafting study proposals, protocols, and reportsAssist in drafting research approval applications to IACUC and IBCCoordinate study related activities with other applicable departments as necessaryCoordinate 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 neededCoordinate and/or participate in day-to-day research activities such as dose preparation, administration, observations, sample collection, and other related research tasksCommunicate study progress to the Investigator and Study Sponsor when requestedTimely reporting of study adverse events to the InvestigatorGeneralTeam Lead duties which include resource scheduling and updating of departmental worksheets in line with good people practices and in accordance with departmental objectivesCoordinate and/or respond to QA, regulatory agency, and sponsor audits in a timely mannerDevelop, validate, and execute novel study modelsIdentify and implement preventative measures in accordance with set instructions and procedures in cases where serious diseases are suspectedControl document development and review as requiredPerform any other related duties as may be required

REQUIRED SKILLS

Research planning, Public health, Specimen collection, Research and development, Data analysis

REQUIRED EDUCATION

Post-graduate education