Senior Clinical Research Coordinator SSMC Abu Dhabi

Senior Clinical Research Coordinator at SSMC in Sheikh Shakhbout Medical City, Abu Dhabi, UAE will receives direction from the research operations manager and principal investigator. Leads and collaborates with other staff involved in research protocol(s). Provides guidance and direction to and works cooperatively with other research staff. Leads and collaborates with various departments within the institution. Builds constructive relationships with all investigators and personnel at all levels, promoting a collaborative culture. Engages directly with research participants, other research centers, and sponsoring companies, leveraging expertise and leadership skills to resolve problems and ensure efficient completion of research studies. Embraces a position of influence and responsibility, actively contributing to the success of research endeavors. This is a Senior level full time job. And salary can range between 10000-20000 AED/month.

Responsibilities of Senior Clinical Research Coordinator

• Coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols in compliance with regulatory laws and Sheikh Shakhbout Medical City (SSMC) policies and guidelines. With minimal direction from the supervisor in compliance with regulatory laws and institutional guidelines.
• Essential document preparation and submission to Institutional Review Board (IRB), or other entities in accordance. With Good Clinical Practice (ICH-GCP), SSMC policies and other applicable laws or regulations.
• Ensures robust implementation of research protocols after Institutional Review Board (IRB) approval, regularly providing updates and progress reports. Screens, enrolls and recruits research subjects.
• Coordinates schedules and monitors research activities and subject participation, addressing any issues or obstacles.
• Leads in the development and implementation of recruitment strategies to increase participant enrollment in clinical trials.
• Conducts or participates in the informed consent process, including answering any questions related to the study.
• Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implement and sign.
• Takes responsibility for Identifying, reviewing, and reporting adverse events (AE)s, serious adverse events (SAE)s, protocol deviations. And other unanticipated problems promptly in accordance with ICH-GCP, SSMC policies and procedures and applicable laws and regulations.
• Manages, monitors, and reports research data to maintain quality and compliance, including oversight of data integrity.
• Designs and implements systems for efficient management of research data and for the tracking of progress of clinical research studies.
• Collaborates with other research staff, sponsors, and senior management to ensure the successful completion of research projects.

What you will do more

• Provides education/training for new and existing research staff members about clinical research practices and ethics within the department.
• Acting as mentor and providing support/guidance for other junior clinical research coordinators.
• Provide senior level consultative expertise regarding trial management, regulatory duties and CTU policy requirements.
• Manages and resolves complex clinical and research-related issues and problems.
• Participates in protocol development activities, through ongoing management of the protocol document and process by editing, amendments, proofing, coordination of study logistics (i.e., blood collection kits, data collection booklets, use of Clinical Trials Unit, etc.). And verification of content to meet SSMC and Department of Health (DOH) standards; communication with study sites and federal agencies regarding study status changes. IRB document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements.

Requirements for Role of Senior Clinical Research Coordinator

• Bachelor’s Degree in one of the medical science disciplines (Nursing, Pharmacy, Biological sciences etc.).
• Graduate or diploma from a study coordinator training program is prefer.
• Minimum of 3 years of experience in clinical research setting or related field.
• ACRP Certification.

Skills And Knowledge Desired

• Knowledge of ICH-GCP, Declaration of Helsinki and local regulations.
• Project management.

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