- This role will be responsible for supporting the Clinical Project Manager (CPM) in the operational management and the oversight of clinical studies within a clinical development program.
- They will be delegated responsibilities to support successful execution of clinical studies from the protocol concept through the clinical study report, ensuring completion of study deliverables.
- They will assist in providing oversight of the vendors on assigned study.
- The Clinical Study Coordinator will work closely with all study team members under the responsibility of the CPM.
Assist the CPM in various functions such as:
- Coordinate development and approval of study documentation such as the study protocol, informed consent form, study-specific guidelines, plans and manuals, regulatory documents, and clinical study report, in accordance with internal SOPs and GCP requirements
- Develop and maintain tools to follow study timelines, milestones, and budget
- Support the selection of Service Providers (SPs) required for the study
- Coordinate forecasting and availability of IMP and study materials
- Coordinate collection of study samples and ensure analysis conducted as planned
- Coordinate feasibility and site qualification process
- Support the conduct of kick-of meeting, Investigator meeting (if any) and CRA training
- Lead relevant meetings (internal and external) to follow study deliverables
- Implement appropriate quality control of all deliverables, internal or from the SPs
- Follow study key performance indicators and issues resolution, internal or from the SPs
- Follow monitoring activities and organize co-monitoring visits to ensure data quality
- Follow study quality with regular check of reports produced e.g. study deviations, follow-up of SAEs, queries …..and take appropriate actions with the CPM
- Track enrolment and retention issues, and follow implementation of actions to keep study on track
- Ensure proper study documentation is maintained and archived in the TMF
- Support the CPM in all reporting activities
- Assist in study budget management and control including review of SPs invoices
Department: Clinical Operations
Direct supervisor: Clinical Operations Support Functions Manager
Internal interactions: all departments
External interactions: service providers involved in study
• At least 5 years of clinical study experience
• On site monitoring experience required
• Bachelor’s degree or equivalent combination of education/experience in science or health-related field required
• Excellent knowledge of GCP/ICH guidelines and the clinical development process
• Excellent communication skills, both verbal and written.
• Fluency in English both written and oral.
• Proficient with Microsoft Office Word and Excel.
• Understanding of MS Project.
• Pro-active and problem-solving attitude, very strong prioritization skills
• Team player, collaborative attitude
• Ability to work independently and prioritize duties.
• Understanding of Electronic Data Capture (EDC).