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 |