Sub Investigator (m/f)

Description

• CISM is looking for a site Sub-investigator for the BOHEMIA clinical trial, to be conducted in Mopeia, Mozambique. The project will be conducted over a total of four years, with the clinical trial active for 2 sequential years during the peak malaria season. The overall goal is to advance the development of a complementary vector control strategy to reduce malaria transmission
• This position may require local and international travel for Institution, Sponsor and Funder led meetings
• Compensation for this position will be based on the applicant’s experience and qualifications. This position starts immediately

Duties

• Serve as site Sub-investigator for the BOHEMIA clinical trial
• Maintain strict confidentiality of participants, employees and company information at all times
• Assist the site PI with the development of site and trial specific documents including but not limited to ICFs, source templates, recruitment plans, trial visit and participant dosing plans
• Familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), study medication(s) and SOPs for the clinical trial
• Work with the site PI to maintain high quality and participant safety
• Ensure participant recruitment, screening and enrolment activities are conducted according to the study protocol, ICH-GCP guidelines, local regulations and requirements and SOPs and per tasks delegated by the site PI
• Perform clinical procedures and assessments as required by the trial protocol and tasks delegated by the site PI
• Dispense investigational product and instruct participants on usage and potential drug interactions as required and per tasks delegated by the site PI
• Identify trial participants hospitalised during the trial safety observation period and provide medical (ward rounds and/or direct treatment) and documentation follow up to the the site PI
• Identify trial participants referred from the district hospital to regional hospitals and provide documentation follow up to the site PI
• Identify trial participants presenting at the district hospital outpatients department and provide documentation follow up to the site PI
• Complete all documentation, paper and electronic in a timely manner as required per protocol to ensure data integrity and per tasks delegated by the site PI
• Attend all monitoring debrief meetings
• Risk identification and escalation to the site PI and CISM
• Issue identification and applicable escalation to the site PI and CISM
• Participate in clinical trial meetings with the site, community, CISM, Sponsor and others as required

Requisites

• MD degree and current license to practice
• Knowledge of and experience in the Mozambique healthcare system
• Proficiency with Microsoft Office (Outlook, Word) and Web applications
• Exceptional organizational skills, attention to detail and follow through
• Fluent Portuguese – written and spoken
• Basic/intermediate written and spoken English (must submit examples of written work)
• Willingness to live in Mopeia for the duration of the trial
• Required personal and interpersonal skills
• Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic
• Results-oriented approach to problem solving
• Accustomed to teamwork and willingness to contribute to elements outside the clinical trial scope
• Ability to work independently where necessary
• Preferred: Previous experience with malaria clinical trials and/or research studies
• Dispensing license (purely as backup to pharmacist)
• Knowledge of spoken local language

Notes

• Only shortlisted applicants will be contacted