Summary
Date Posted: Tuesday, October 24 2023, Base Salary: Not Disclosed

JOB DETAILS:
General Summary
The Clinical Trials Monitor will work closely with the Clinical trials manager and the Team Lead for Internal monitors to ensure that the IDI research monitoring framework is strengthened.

Key Responsibilities
• Participate in the following monitoring activities of research studies at IDI to ensure compliance with approved study protocols and human participants’ protection:
• Ensure that risk assessment is conducted for the protocols and guide the development of a risk-based monitoring plan.
• Ensure that the study teams are adequately trained on the protocol, background, and relevant SOPs prior to the conduct of any study activities
• Maintain regular communication with the Principal Investigators (PIs) and Study Coordinators (SCs) including scheduling monitoring visits, monitoring recommendations, and their resolution.
• Evaluate conformance to the protocol, protection of human participants’ regulations, pharmacy and laboratory methods, GCP and GCLP
• Verify that the investigator has adequate qualifications and resources that remain adequate throughout the study period and that the study teams and facilities, including laboratories, pharmacy, and equipment, are adequate to safely and properly conduct the study and these remain adequate throughout the study period.
• Verify that the investigator follows the approved protocol and all approved amendments, if any.
• Verify that written informed consent is obtained before each participant's participation in the study.
• Verify that the investigators and the study teams are performing the specified study functions, in accordance with the protocol and any other written agreement between the sponsor and the investigator/institution, and have not delegated these functions to unauthorized individuals.
• Verify that the investigator is enrolling only eligible participants.
• Review the participant screening and enrolment rate and support studies accordingly.
• Verify that source data, documents, and or CRF, other study records are accurate, legible, contemporaneous, original, attributable, and complete. Additionally, verify that source data is in correspondence with the data on the CRFs and database successively
• Verify that the investigator provides all the required reports, notifications, applications, and submissions and that these documents are accurate, complete, timely, legible, dated, and properly filed in the regulatory binder to identify the study.
• Ensure that missed visits, tests, and examinations that were not conducted as well as withdrawals and dropouts of enrolled participants are clearly documented on the CRFs and in accordance with the study protocol, SOPs, and manual (s).
• Ensure that appropriate corrections, additions, or deletions are made, dated, explained (if necessary), and initialed by the investigator or by a member of the investigator's trial staff who is authorized to initial CRF changes for the investigator.
• Ensure that all deviations from the protocol, SOPs, manual (s), GCP, and the applicable regulatory requirements are communicated to the investigator with appropriate action to correct the deviation (if possible) and actions designed to prevent the recurrence of the detected deviations.
• Review reports including SAEs, abnormal laboratory values, data QCs, specimen QCs, monthly reports, etc.
• Ensure timely submission of written monitoring reports for review by the Clinical Trials Manager
• Provide approved monitoring reports with the PIs and SCs
• Ensure that recommendations highlighted in monitoring visit reports are addressed in a timely manner
• Participate in development of the Quality Improvement projects based on the recurrent monitoring findings
• Participate in regular research office and monitor team update check-in meetings.
• Ensure awareness of updated national and international ethical guidelines
• Execute any other duties as may reasonably be assigned by the research office.

Person Specification
• A Bachelor’s degree in a health-related subject is required
• A master's degree in Public health, Bioethics, and any other related fields are an added advantage
• Certified Clinical Research Associate by a recognized body.
• A minimum of 3 years of clinical trial monitoring in a busy research institution.
• Understanding of clinical trials monitoring frameworks
• Demonstrated strong report-writing skills
• Pays attention to details
• Good oral and written communication skills
• Good presentation skills including PowerPoint
• Demonstrated initiative and self-management skills
• Demonstrated strong problem-solving skills
• Demonstrated ability to build and maintain relationships with individuals and teams
• Willing to learn and able to work with minimal supervision
• Excellent computer skills


Work Hours: 8

Experience in Months: 36

Level of Education: Bachelor Degree

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