The Fatty Liver Diseases Program under the direction of Dr. Mazen Noureddin is looking for a Clinical Research Coordinator III. The Clinical Research Coordinator III works independently providing study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. Plans and coordinates strategies for increasing research participant enrollment, improving efficiency, training of personnel, and identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Responsible for oversight of all studies within the group and the assignment of studies to clinical research personnel within the group. Manages the clinical research portfolio and daily operations of studies for the investigator or disease group.
Independent study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details to the research participants, and participating in the informed consent process.
Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research participant billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Works with Training and Education Coordinator to ensure all staff is properly trained and certified.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.
Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
Identifies new research opportunities and presents to investigators.
Supervises other clinical research staff in day to day operations. Provides input in the performance review of other clinical research staff.
Organizes and leads routine research meetings.
Manages and grows human sample collection for repository as well as research databases of the Fatty Liver Disease Program
Works on both industry sponsor initiated and investigator initiated clinical trials
Provides training to junior level coordinators
Bachelor of Science or Bachelor of Arts Degree.
ACRP/SOCRA (or equivalent) certification preferred.
Minimum (5) years of directly related experience required
Ability to follow detailed instructions and protocols, oral and written.Working knowledge of laboratory equipment and research protocols.
Knowledge of computer analysis techniques and ability to provide routine analysis and interpretation of research data.
Working knowledge of database management, personal computers, and presentation and imaging software.
Must possess computer skills to include, but not limited to, Excel and Word.
Physical Demands: (e.g., lifting, standing, walking)
Ability to perform moderate lifting, sit, stand and walk for prolonged periods of time. Able to operate standard office equipment, exercise physical ability and satisfactorily perform essential job functions.