The project
BOHEMIA (Broad One-Health Endectocide-based Malaria Intervention in Africa) is a UNITAID funded project conducting a cluster randomised controlled trial (cRCT) to evaluate ivermectin mass drug administration (MDA) for malaria prevention in Kwale county.
The BOHEMIA project is searching for a clinical lead with experience in clinical trial research. The candidate will supervise clinical officers and will be supported by a pharmacy team and a field operations team. The clinical lead will be responsible for safety trial monitoring, communicating and assisting study monitors, evaluation and reporting of AEs, SAEs and SUSARs, as well as, assisting with reports to sponsor and regulatory authorities.
KEY RESPONSIBILITIES:
Lead the safety monitoring of the BOHEMIA clinical trial.
Supervise and manage a team of clinical officers.
Development of study monitoring documentation including SOPs, SSPs, training manuals, operations manuals and logs.
Assist with staff training where appropriate.
Establish a safety monitoring reporting system between the field staff, the clinical team and the Sponsor.
Carry out an evaluation for every registered SAE and fill out follow up reports.
Complete all reports in a timely manner in order to guarantee participant safety.
Participate in all monitoring related meetings and assist the clinical trial team during the monitoring visits
Address the monitoring team findings of the clinical trial
Identify any risks or issues of the clinical trial and communicate them to the PI and clinical trial team.
QUALIFICATIONS:
Holders of Bachelor of Medicine and Bachelor of Surgery (M.B;Ch.B.) degree or its equivalent degree from any recognized university or institution.
1-3 years post qualification experience
Valid clinical practice license and annual retention certificate from the Kenya Medical Practitioners and Dentists’ Board or equivalent
Experience in clinical trials.
Knowledge of human research ethics and Good Clinical Practices (GCP).
Proficiency in Microsoft Office (Word, Excel).
Certification in GCP and RETC.
Desirable:
Experience working in Kwale (desirable but not essential).
COMPETENCIES:
Demonstrate high levels of integrity and confidentiality
Excellent interpersonal, written, presentation and communication skills and a high level of emotional intelligence
Good analytical, problem solving and critical thinking skills;
Teamwork and ability to work with diverse teams
Strong Flexibility, adaptability, multi-tasking and attention to detail
Strong team coordination and Supervisory skills.
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