Healthcare and MedicalFull-TimeSenior-level(6+ yrs)
Job Description
The Clinical Research Facilities (CRF) Study Manager at the International Livestock Research Institute (ILRI) is responsible for the oversight and management of clinical research studies. This senior role involves acting as a primary Investigator or Assistant Study Investigator, managing complex research protocols, budgets, and regulatory approvals, while ensuring the health and welfare of both personnel and animals involved in the studies.
Key Responsibilities
Investigator Duties
Serve as Investigator on studies as appointed by Test Facility Management.
Lead the drafting of study protocols and budget development, including protocol writing, editing, and technical review.
Draft and submit research approvals to Institutional Animal Care and Use Committees (IACUC) and Institutional Biosafety Committees (IBC).
Secure all necessary approvals from national and international authorities such as the National Biosafety Authority (NBA), NACOSTI, Directorate of Veterinary Services (DVS), and NEMA.
Monitor adherence to the Biosafety Manual and animal welfare policies to ensure the safety of personnel and animals.
Oversee the receipt, dispensing, and disposal of investigational veterinary products and imported biological materials according to local regulations and internal SOPs.
Manage study phases outsourced to external laboratories, consultants, or vendors.
Provide guidance and technical training to research staff.
Coordinate day-to-day research activities including dose preparation, administration, sample collection, and clinical observations.
Assistant Study Investigator Duties
Provide lead support to Investigators on assigned studies.
Administer study master files, including preparation, close-out, raw data reviews, and data management.
Assist in drafting study proposals and research approval applications.
Coordinate activities across applicable departments and manage study setup (facility logs, animal selection, and scheduling).
Ensure timely reporting of study adverse events to the Investigator.
General Management
Perform Team Lead duties including resource scheduling and updating departmental worksheets.
Respond to Quality Assurance (QA), regulatory agency, and sponsor audits.
Develop, validate, and execute novel study models.
Identify and implement preventative measures for suspected serious diseases.
Requirements
Masters degree in Natural or Biological Sciences.
At least 7 years of relevant research or clinical study experience.
Deep expertise in animal health, animal welfare, biosecurity, and the 3Rs concept (Refine, Replace, and Reduce).
Familiarity with VICH GL9 (Good Clinical Practice).
Experience with qPCR and immune assays (ELISA, IFN-y ELISpot, and VINT) is highly desirable.
Strong ability to work in a multi-cultural environment and lead teams with limited supervision.
How to Apply
Interested and qualified candidates should apply online via the ILRI application portal. Visit www.ilri.org or use the direct link: Apply Now.
How to Apply
Interested and qualified candidates should apply by visiting the International Livestock Research Institute (ILRI) portal on www.ilri.org. Alternatively, you can apply directly through the application link: https://www.myjobmag.co.ke/apply-now/1215137.