AKU invites applications for the position of Clinical Operations Lead, Clinical Research Unit (CRU), Department of Haematology/Oncology
The CRU Clinical Operations Lead will be responsible for the day to day clinical operations of the clinical research unit. The candidate will plan, coordinate, and execute all aspects of clinical care and oversight of patients on clinical trials – screening, consenting, on-study treatment and end of study documentation. The Clinical Operations Lead (COL) will assist the PI in feasibility assessment and review of clinical trials protocols. The COL will be responsible for preparing study documents, providing input in the development of research budgets, provide assistance to the regulatory department with regards to human subject consent and keeping up with study amendments. The COL will provide leadership in screening patients for eligibility, consenting patients and the clinical aspects of on-study care. The COL will oversee the day to day activities of all clinical personnel involved in the execution of a clinical trial.
Responsibilities
- Develop/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents
- Plan, coordinate and execute all clinical trials studies conducted through CRU
- Ensure risk management strategies are in place and followed in the CRU
- Plan, execute, and lead study specific meetings (initiation meetings, site monitoring, ongoing and follow up meetings,) with sponsors and investigators and develop action plan
- Develop capacity-building and trainings for CRU and other AKU staff involved in human subjects research
- Assist in conducting workshops and research training for SOM/SONAM faculty
- Participate in the planning of quality assurance activities and coordinates resolution of audit findings
Requirements
- Master’s degree in any of the health fields (Nursing, Bioethics, Clinical Research, Public Health)
- Minimum 3 to 5 years of work experience in clinical research, of which at least 2 years should have been spent directly in clinical trials
- Current knowledge of best practices in clinical research, including active participation in international organizations, such as AACI, CRI, SOCRA, or ACRP
- Knowledge and experience in dealing with clinical, regulatory and pharmacy staff as it relates to clinical trials implementation
- Excellent multitasking skills and ability to work under pressure, strong team leading and delegation qualities
- Superior understanding of and making budgets
- Proficiency in the use of computers and related office software.
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