About St. Kitts Biomedical Research Foundation
The St. Kitts Biomedical Research Foundation (SKBRF) is a research organization devoted to advancing the development of therapies for human diseases and the application of related models of disease pathophysiology to drug and device evaluation. SKBRF applies extensive expertise in many areas of therapeutic and diagnostic research for which clinically relevant models are feasible, with a focus on ophthalmic, central nervous system and metabolic research, as well as pharmacokinetic and safety studies.
Job Summary
The Study Coordinator (SC) participate in the day-to-day planning and organization of studies by working with multiple departments to coordinate activities. The SC oversees the conduct of animal research according to regulatory guidelines, protocols, and standard operating procedures (SOPs). The SC is additionally responsible for assisting Study Directors (SD) in monitoring the overall conduct of study execution.
Key Accountabilities of the Role
- Protocol Development: Reviews study protocol and provides feedback for improvement as appropriate. Participates in pre-initiation and other study related meetings. Additionally manages documentation of SD replacement in according to established SOPs.
- Study Execution Support: Generates and manages study related documents (e.g. study materials list from SEP, cage and sample labels, datasheets, subject recruitment files) and uploads to Wrike while tagging relevant parties.
- Communication: Proactively communicates and interacts with study team (SDs and operational staff) to ensure key milestones are achieved. Sends calendar invites to SD for all critical time points from study plan development to report finalization.
- Data Management: Oversee data acquisition, documentation, quality control, and management in accordance with study protocols and standard operating procedures (SOPs). Manages the study binder.
- Documentation: Assist the SD to ensure all study data and events, including protocol deviations and observations of unanticipated responses of the test system, are accurately documented, and verified at the time that they occur, and appropriate corrective action is taken and documented. Document animal health concerns in the study files and DvMax and additionally alert the veterinary team.
- QC/QA: Ensure study data (paper and electronic records) and study reports undergo appropriate quality control and Quality Assurance (QA) review, as appropriate, prior to reporting. Reviews QAU report audits with SD or appropriate.
laboratory group; contributes to audit; works with the SD, Study Coordinator I or Study Coordinator II to ensure that all necessary report/raw data clarifications are completed, and study data are appropriately archived.
- Sponsor Communication: Participates in routine client visits under direction of the SD. Manages complete ‘pdfing’ of client communication for GLP studies.
Qualifications
1. Education level/Certifications/Licensures
• Associate degree
2. Experience
• Minimum 2 years laboratory experience working with in vitro and/or in vivo models, preferably including nonhuman primate translational models.
3. Specific competencies
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills and ability to meet deadlines.
• Ability to prioritize tasks.
• Ability to function well in a high-paced and time pressured environment.
• Proficiency with Microsoft Office Suite.
Interested candidates may send their resumes directly to the attention of Akela Edinborough via email address skrecruitment@virscio.com, on or before May 9, 2024.
Contact Information
Company St. Kitts Biomedical Research Foundation
Department Human Resources Department
Address P. O. Box 6018, Lower Bourryeau Estate, St. Kitts
Phone (869) 465-7382
