Deputy Internal Monitor Epicentre

You are looking for a meaningful professional experience?
Deputy Internal Monitor, responsible for the protection of study participants rights and safety, preserving the quality and integrity of data being collected during the course of the study.

Main accountabilities/ responsibilities:
• Lead in drafting, developing and revising the study specific Monitoring Plan.
• Develop, maintain, organize and update the Investigator Site File Binder and the electronic ISF on share point.
• Participate and Support Site Initiation Visits, Routine Monitoring Visits and Site Close Out Visits
• Monitor Informed Consent Form regularly as soon as Participants are enrolled.
• Participate in frequent monitoring of recruitment activities of the study e.g screening and enrolment process to verify that the investigator is enrolling only eligible subjects and support to ensure the logs and tracking tools are complete.
• Participate frequently in Study Source Data Verification against Case Report Form before or after Data entry for consistency, completeness, accuracy and validity.
• Monitor to ensure study tests, study visits and any other study procedures are conducted as per protocol and standard operating procedures.
• Verify that equipment in use for the study are calibrated, serviced and certification provided or documentation done according to the user standard Operating procedures.
• Monitor the Laboratory to ensure all study documentation are in place.
• Sample and documentation Monitoring before shipment is done.
• Monitor the Pharmacy to ensure all equipment are serviced and all documentation is in place.
• Investigational Product accountability, Participant prescription and concomitant monitoring.
• Submit timely Monitoring Visit reports to the Study Coordinator and sponsor at pre agreed frequency.
• Participate, support and coordinate external monitoring and audit visits as pre agreed with the Study Coordinator, Principal Investigator, Research Regulatory Administrator and the sponsor.
• Participate in regular update calls with studies, departments, Sponsors and/or external monitor, provide study related monitoring updates and document the meeting minutes.
• Liaise/ work closely with other departments and support the Study Coordinator in staff Training needs assessment.
• Communication skills : you will be expected to have good writing skills, excellent interpersonal skills, excellent organization skills and time management, strong attention to detail, self motivated and strong leadership skills.

Qualifications
• Education and Professional experience : You have Bachelor’s Degree in any health related field (Mandatory)
• You have a minimum of four years relevant previous working experience.
• You have a good knowledge of ICH guidelines, GCP, clinical trial study process.
• Previous experience in clinical research (preferred)
• You have excellent written and oral communication skills in English.
• Research Ethics, Report writing, Clinical Research Monitoring & Computer literacy (Word, excel, power point, share points, teams etc).
• You will be expected to have excellent organisational and planning skills, and an ability to work within a multi-disciplinary, multi-cultural, motivated and competent team.
• You have a proven ability to work under pressure, to be thorough, flexible and adaptable. You have good scientific writing skills, good communication and presentation skills. You work well in a team and are proactive in proposing new approaches and solutions.