Clinical Trials Coordinator
NK Basile Administration
Deadline Dec 08 2021
The NK Basile Administration has an opening for the position of Clinical Trials Coordinator above grade 12. Since this provides an opportunity for PROMOTION from within, kindly circulate this information and/or post it in your area of jurisdiction so that those interested and having the minimum qualifications may apply.
Basic Functions
Coordinate and oversee the planning, implementation, execution, and reporting of clinical research trials at the Naef K. Basile Cancer Institute (NKBCI) at AUBMC. Facilitate communication between institutional and departmental constituents concerned with the conduct of clinical research at the NKBCI. Prepare periodic progress reports on the activities of clinical research at the NKBCI. Manage the activities related to the planning and initiation of clinical trials, records keeping, and follows-up on the various issues at hand in a timely fashion.
Support the mission and vision of the American University of Beirut Medical Center (AUBMC) and that of the Department.
Minimum Requirements
  • Bachelor's Degree in Nursing or Health Sciences. Master's Degree in Nursing or Health Sciences is preferred.
  • 2 years of experience in Nursing or Clinical Research.
  • Strong command of Arabic and English (EEE >/= 500).
  • Proficient use in Microsoft Office Applications and other software, when needed.
  • Work Schedule: Regular weekdays


Interested applicants are invited to register/login and complete the online application and apply to the vacancy prior to December 08 2021 on the following link: http://www1.aubmc.org.lb/hremp/

For Internal Applicants: In addition to the updated C.V., a letter of intent should be addressed to the Human Resources Department with a copy to the concerned Supervisor(s).

Within the framework of Lebanese Law, the American University of Beirut is an equal opportunity employer.
Job Summary
Coordinate and oversee the planning, implementation, execution, and reporting of clinical research trials at the Naef K. Basile Cancer Institute (NKBCI) at AUBMC. Facilitate communication between institutional and departmental constituents concerned with the conduct of clinical research at the NKBCI. Prepare periodic progress reports on the activities of clinical research at the NKBCI. Manage the activities related to the planning and initiation of clinical trials, records keeping, and follows-up on the various issues at hand in a timely fashion.
Support the mission and vision of the American University of Beirut Medical Center (AUBMC) and that of the Department.
Essential Functions / Task Groups

Database Tasks:

Coordinate activities related to the development and maintenance of e-forms with the NKBCI faculties and IT department.
Oversee patient enrollment process in the oncology database in coordination with several departments.
Ensure patient recruitment process is aligned with the approved protocol.
Collect, enter and update patient data into the e-forms.
Ensure data safety and quality is maintained though periodic auditing.
Ensure all aspects of data collection and patient recruitment are in line with the IRB approval.
Keep organized database records and documentations including IRB documents.
Prepare periodic data completeness statistical reports for the NKBCI faculty and develop action plans to maintain high data completeness percentage (90%).
Provide periodic statistical administrative data to the NKBCI administration for strategic and clinical quality improvement.
Prepare and clean database data for clinical research projects only subject to the IRB approval.
Ensure protocol submission and revision in compliance with the IRB policies and procedures.
Train, supervise and overlook data registrar case detection, data collection and data entry.

Functional/Technical Duties:

Coordinate activities related to the conduct of clinical research within the NKBCI, and between the various constituents involved in the conduct of clinical research.
Plan and coordinate patient schedule for study procedures, return visits, and study treatment schedules.
Oversee and implement research trial(s) throughout their stages of development.
Manage all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form/and adverse event reports.
Oversee subject recruitment, informed consent, screening and inclusion of subjects.
Educate patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.
Perform assessments at visits and monitor for adverse events.
Coordinate and oversee data collection, forms, and all other activities related to ongoing clinical research.
Duties includes consent forms; data collection forms, ensuring protocol adherence.
Coordinate the data collection and management, collection of source documents, using and developing CRFs, registration and management AEs, filing and archiving, managing monitoring visits, dealing with queries.
Close the clinical trial, contributing to research article, audit preparation, trial closure, communication with authorities and other disciplines involved, assisting in the final study report and completion.

Administrative / Miscellaneous Duties:

Ensure Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulator/agency specifications.
Prepare and maintain protocol submissions and revisions.
Prepare periodic reports related to the conduct of clinical research.
Keep organized records of office functions and sets objectives to improve efficiency of the operations within the NKBCI.
Oversee and maintain documentation of all needed paperwork for oversight agencies, including IRB.
Maintain accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
Coordinate communications with the IRB.
Ensure compliance with IRB policies and oversight.
Coordinate communication with authorities, site visits, and product accountability.

Critical Competencies
Achievement Orientation, Client Focus, Communication Skills, Computer Skills, English Comprehension, Ethical Practice, Evidence Based Practice, Health education, prevention and promotion, Information and Records Administration, Initiative, Organizational Awareness, Patient Assessment, Planning and Organizing, Problem Solving, Professional Development, Professionalism, Quality Management, Safety and Health Management, Stress management, Team Skills, Technical Expertise.
Knowledge / Know-How
Knowledge:
Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines required.
Proficient in statistical analysis.

Education:
Minimum Education: Bachelor's Degree in Nursing or Health Sciences.
Preferred Education: Master's Degree in Nursing or Health Sciences.

Experience:
Minimum Experience: 2 years of experience in Nursing or Clinical Research.

Languages:
Minimum Languages: Arabic and English (EEE >/= 500).

Computer Skills:
Proficient use in Microsoft Office Applications and other software, when needed.
Impact of Actions / Decisions
Carrying out work effectively affects positively the image of AUBMC and increases efficiency of work processes and accelerates the improvement initiatives.
Job Structure
Devise work methods according to general directives, policies and specialized professional standards.
Managerial / Supervisory Responsibility
Reporting Channel:
1st Level: Professor of Clinical Medicine
2nd Level: Director of the Naef K. Basile Adult Cancer Institute

Supervisory Channel:
None
Job Characteristics
Physical Effort:   Little or no Physical Effort
Work Schedule:   Regular weekdays
Working Conditions:   Exposed to patient element