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JOB SUMMARY

The Clinical Research Monitorensures compliance of the clinical research with the currently approved protocol/amendment(s), with all applicable regulatory policies and guidelines, including Good Clinical Practice (GCP), as well as with Sidra’s policies and procedures. S/he assists in the design, development, implementation, and conduct of an effective monitoring program in accordance with GCP, institutional policies and procedures, and research protocols.

As such, the clinical research monitor performs a quality control measure to ensure the integrity of research data and protection of the rights and well-being of study participants.

The Clinical Research Monitor should monitor all study related procedures and documentation such as Informed Consent Form, Source Documentation and CRF review, Adverse Events, Serious Adverse Events and Unanticipated Problems, Investigational Product (IP) (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, recruitment strategies

The Clinical Research Monitor ensures that, for those clinical research studies assigned for monitoring, the appropriate and required monitoring tasks and related activities occur as outlined in the monitoring plan or as per the procedure “Monitoring for clinical research and clinical trials” and in compliance with all related regulatory standards. S/he monitors if the reported study data is accurate, complete, and verifiable from source documents, and captures all inconsistencies observed during the clinical research studies in order to prevent recurrence on non-compliance with established regulatory standards.

The Clinical Research Monitor is responsible for multiple projects at a time, and must have strong time management skills in addition to working both independently and in a team environment.

Responsibilities

KEY ROLE ACCOUNTABILITIES

• Ensures that the Investigator and study team follow the approved protocol and all approved amendment(s), if any, and adhere to current regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including Monitoring standards and guidelines.

• Ensures 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.

• Adheres to the protocols’ Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.

• Performs study conduct trainings to research teams such as Site Initiation Visits for Clinical Trials and Initial Site Trainings for Clinical Research

• Develops and updates Study conduct training materials as requested for researchers and study conduct templates as needed.

• Assists in the development and writing of clinical research monitoring plans.

• Conducts the monitoring visits, writes the monitoring report in details by summing up the findings of the monitoring process and put the corrective/prevention action plan for these findings. The CRM then reports to the next in line authority for approval. Issues the letter to the principal investigator and follows up with the PI to close the findings.

• Verifies 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 the applicable regulatory requirements.

• Verifies that the investigator has adequate qualifications and resources documented in their study investigator sites files and remains adequate throughout the study period.

• Validates that the investigator and the investigator’s study team are adequately informed about the study through their training records.

• Verifies that the investigator is enrolling only eligible subjects and reports subject recruitment rate.

• Verifies that written informed consent was obtained from each subject before participation in the study.

• Verifies subjects are provided with necessary instruction on properly using, handling, storing, and returning the investigational product(s).

• Checks 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, verifies that study data entered on the CRFs is consistent with patient clinical notes and other source documentation (source data verification), and Informs the investigator of any CRF entry error, omission, or illegibility. Ensures as well that proper corrective plan is taken as per ICH-GCP standards.

• Verifies that all withdrawals and dropouts of enrolled subjects from the study are reported and explained on the CRFs.

• Checks 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 the applicable regulatory requirement(s). In case of any unreported AEs / Ups, the CRM has to report this on the monitoring report and ask the PI to report it to the IRB

• Verifies that the investigator provides all the required reports, notifications, applications, and submissions and that these documents are accurate, complete, timely, and legible, dated, and identify the study.

• Determines whether the investigator is maintaining the essential documents in their regulatory study binders.

• Meets expected timelines for completion of monitoring activities and submission of written monitoring reports.

• Track and report all issues identified through the monitoring visits on the monitoring tracking tools

• Communicates deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and ensures appropriate action is designed to prevent recurrence of the detected deviations. Communicate to HRPP Director and IRB Office any critical or major deviation/violation that would require intervention from these offices promptly.

• Adheres to Sidra’s standards as they appear in the Code of Conduct and Conflict of Interest policies

• Adheres to and promotes Sidra’s Values

Qualifications

QUALIFICATIONS, EXPERIENCE AND SKILLS – SELECTION CRITERIA

ESSENTIAL

PREFERRED

Education

Bachelor’s degree in biology, health/ biomedical sciences or equivalent

Master's degree in biology, health/ biomedical sciences or equivalent

Experience

• 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 CRO (contract research organization).

Certification and Licensure

Association of Clinical Research Professionals – Certified Clinical Research Associate (ACRP-CCRA) or willingness to obtain within the 1st 2 years of recruitment

Certified Clinical Research Professionals (SOCRA) or willingness to obtain within the 1st 2 years of recruitment