Co-Principal Investigator for the BOHEMIA clinical trial Mopeia site
The Manhiça Health Research Centre (CISM), established in 1996 and represented by the Fundação Manhiça, a legal Mozambican entity established in 2008, aims at conducting and promoting health research in national priority health areas to safeguard the health of the most vulnerable populations.
CISM is looking broadly for an experienced Site Co--Principal Investigator (Co-PI) 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.
Essential duties and responsibilities:
- Serve as Mopeia site Co-PI for the BOHEMIA clinical trial and conduct all aspects of the clinical trial strictly to ICH-GCP standards.
- Be the primary person responsible for the preparation, tracking and submission of relevant documents to all relevant local and national authorities and ethical committees to obtain clinical trial approval in accordance with Sponsor requirements.
- Maintain strict confidentiality of participants, employees and company information at all times.
- Assist 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.
- Thoroughly 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 Principal Investigator (PI) and Study Clinician to maintain high quality and participant safety.
- Delegate study responsibilities as appropriate and ensure necessary training and qualifications of clinical trial team members.
- Guide and oversee the clinical trial team in the conduct of the BOHEMIA clinical trial, according to the study protocol, ICH-GCP, local and international regulations and SOPs.
- Ensure participant recruitment, screening and enrolment activities are conducted according to the study protocol, ICH-GCP guidelines, local regulations and requirements and SOPs.
- Perform clinical procedures and assessments as required by the study protocol.
- Dispense investigational product and instruct participants on usage and potential drug interactions as required.
- Complete all documentation, paper and electronic in a timely manner as required per protocol to ensure data integrity.
- Maintain responsibility for the Investigator Site File and archiving of thereof.
- Provide project status updates and reports to CISM and the Sponsor as required.
- Be present for all monitoring visits and attend all monitoring debrief meetings.
- Risk identification and escalation to CISM and the Sponsor.
- Issue identification and applicable escalation to CISM and the Sponsor.
- Coordinate, manage and participate in clinical trial meetings with the site, community, CISM, Sponsor and others as required.
- Provide training for collaborating physicians and clinic nurses on BOHEMIA protocol and investigational product.
- MD degree .
- Experience as Principal Investigator or Sub-investigator/Trial clinician on at least 1 clinical trial submitted to international regulatory agencies that was ICH-GCP compliant.
- Practical knowledge of clinical trial document processes and reporting of SAEs, non-compliances, annual reapproval, progress reports, CRFs, ICFs, etc.
- Current ICH-GCP certification.
- Leadership and management of clinical trial teams.
- Proficiency with Microsoft Office (Outlook, Word) and Web applications.
- Exceptional organizational skills, attention to detail and follow through.
- Excellent written and spoken English (must submit examples of written work)
- Willingness to live in Mopeia or within reasonable travelling distance during the active period of the trial.
Required personal and interpersonal skills
- Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads.
- Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic.
- Results-oriented approach to problem solving.
- High professional standards for clinical trial execution and reporting.
- Accustomed to teamwork and willingness to contribute to elements outside the clinical trial scope.
- Ability to work independently where necessary.
- African national.
- Previous experience with malaria prevention clinical trials.
- Previous experience in malaria-endemic countries.
- Portuguese mid/ proficient level in reading/writing/speaking)
- 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.
- Interviews will be done on a rolling basis.