Clinical Research Monitor

Role Overview

Clinical Research Monitor at Sidra Medicine. This is a full-time role based at Sidra Medicine's facility.

Company Overview

Sidra Medicine is a high-tech healthcare facility representing the vision of Her Highness Sheikha Moza bint Nasser, who serves as its Chairperson. The organization is home to world-class patient care, scientific expertise, and educational resources. Sidra provides comprehensive specialist healthcare services for children and young people, and exceptional maternity, gynecology, and reproductive medical services for women.

Role Purpose

The Clinical Research Monitor ensures compliance of clinical research with approved protocols, amendments, and all applicable regulatory policies and guidelines including Good Clinical Practice (GCP), as well as with Sidra's policies and procedures. The role performs quality control to ensure the integrity of research data and protection of the rights and well-being of study participants. The Clinical Research Monitor assists in the design, development, implementation, and conduct of an effective monitoring program in accordance with GCP, institutional policies, procedures, and research protocols.

Key Responsibilities

Protocol and Regulatory Compliance

• Ensure that the Investigator and study team follow the approved protocol and all approved amendments, and adhere to current regulations, applicable ICH/GCP guidelines, local policies, and standard operating procedures, including monitoring standards and guidelines.
• Adhere to the protocols' Monitoring Plans, including monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring-related tools and templates.
• Communicate deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensure appropriate action is designed to prevent recurrence of detected deviations.
• Communicate to HRPP Director and IRB Office any critical or major deviation or violation that would require intervention from these offices promptly.
• Monitor all study-related procedures and documentation including Informed Consent Form, Source Documentation, CRF review, Adverse Events, Serious Adverse Events, Unanticipated Problems, Investigational Product (if applicable), Laboratory and Specimen Management, Protocol Deviations/Violations, Investigator Site File (ISF)/Study binder, Roles and Responsibilities of site staff, Facilities appropriate to study execution, and Enrollment target and recruitment strategies.

Investigator and Site Oversight

• Ensure that the investigator and the investigator's study team are performing the specified study functions in accordance with any other written agreement between the sponsor and the investigator, and have not delegated these functions to unauthorized individuals.
• Verify that the investigator has filed the current Investigator's Brochure, all documents, and all study supplies needed to conduct the study properly in their study investigator sites files and comply with applicable regulatory requirements.
• Verify that the investigator has adequate qualifications and resources documented in their study investigator sites files and remains adequate throughout the study period.
• Determine whether the investigator is maintaining the essential documents in their regulatory study binders.
• Validate that the investigator and the investigator's study team are adequately informed about the study through their training records.

Training and Development

• Perform study conduct trainings to research teams such as Site Initiation Visits for Clinical Trials and Initial Site Trainings for Clinical Research.
• Develop and update Study conduct training materials as requested for researchers and study conduct templates as needed.
• Assist in the development and writing of clinical research monitoring plans.

Subject Enrollment and Informed Consent

• Verify that the investigator is enrolling only eligible subjects and report subject recruitment rate.
• Verify that written informed consent was obtained from each subject before participation in the study.
• Verify that subjects are provided with necessary instruction on properly using, handling, storing, and returning the investigational product(s).

Data Integrity and Verification

• Monitor that the reported study data is accurate, complete, and verifiable from source documents.
• Check that data required by the protocol are reported accurately on the Case Report Forms (CRF)/study data collection sheets and are consistent with the source documents.
• Verify that study data entered on the CRFs is consistent with patient clinical notes and other source documentation through source data verification.
• Inform the investigator of any CRF entry error, omission, or illegibility.
• Ensure that proper corrective plan is taken as per ICH-GCP standards.
• Verify that all withdrawals and dropouts of enrolled subjects from the study are reported and explained on the CRFs.
• Capture all inconsistencies observed during clinical research studies in order to prevent recurrence of non-compliance with established regulatory standards.

Adverse Event and Safety Reporting

• Check whether all adverse events (AEs) and unanticipated problems (UP) are appropriately reported within the time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and applicable regulatory requirement(s).
• Report any unreported AEs or UPs on the monitoring report and ask the PI to report it to the IRB.

Monitoring Visits and Reporting

• Conduct monitoring visits, write detailed monitoring reports by summarizing the findings of the monitoring process, and put forward corrective and prevention action plans for these findings.
• Report to the next in line authority for approval.
• Issue the letter to the principal investigator and follow up with the PI to close the findings.
• Meet expected timelines for completion of monitoring activities and submission of written monitoring reports.
• Track and report all issues identified through monitoring visits on monitoring tracking tools.

Documentation and Compliance

• Verify that the investigator provides all required reports, notifications, applications, and submissions and that these documents are accurate, complete, timely, legible, dated, and identify the study.
• Adhere to Sidra's standards as they appear in the Code of Conduct and Conflict of Interest policies.
• Adhere to and promote Sidra's Values.

Project Management

• Manage multiple projects at a time with strong time management skills.
• Work both independently and in a team environment.

Qualifications & Experience

• Bachelor's degree in biology, health/biomedical sciences, or equivalent.
• 5+ years of experience in a related field in an international EMA/FDA regulated environment as a clinical research monitor/associate or research quality assurance in a pharmaceutical company or Contract Research Organization (CRO).
• Association of Clinical Research Professionals – Certified Clinical Research Associate (ACRP-CCRA) or willingness to obtain within the first 2 years of recruitment.
• Certified Clinical Research Professionals (SOCRA) or willingness to obtain within the first 2 years of recruitment.

Additional Information

• Preferred qualification: Master's degree in biology, health/biomedical sciences, or equivalent.
• Full details are available on the employer's original posting.