Clinical Research Facilities (CRF) Study Manager

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.