The Department of Medicine at the Keck School of Medicine is looking for a Research Coordinator I to join its GI/Liver team. The Research Coordinatorâs role is to support, facilitate and coordinate the daily activities of clinical research in Gastroenterology. The Research Coordinator works with and under the supervision of the clinical principal investigator (PI), as well as with the department, sponsor, and institution to assist with recruitment, data collection, IRB submission and other related aspects of clinical studies.
Specific job accountabilities will be:
â¢ Coordinates with Principal Investigator(s), department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures.
Protocol Preparation & Review
â¢ Collaborates with the PI to prepare IRB and any other regulatory submission documents.
â¢ Prepares other study materials as requested by the PI.Â These study materials include, but are not limited to, informed consent documents, case report forms (CRFs), enrollment logs, and data collection forms.
â¢ Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
Conduct of Research
â¢ Reviews and develops knowledge of the protocol, e.g. timelines, inclusion/exclusion criteria, confidentiality, privacy protections.
â¢ Assists in communication of study requirements to all individuals involved in the study.Â
â¢ Collects documents needed to initiate study and submit to sponsor (ie FDA Forms, CVs, etc)
â¢ Assists in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study.Â Assures that amended consent forms are appropriately implemented and signed.
â¢ Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participantâs eligibility or exclusion.
â¢ Registers participants to the appropriate coordinating center
â¢ Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
â¢ Coordinates participant tests and procedures.
â¢ Collects data as required by the protocol and completes Case Report Forms.
â¢ Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and USC Investigational Drug/Device Accountability.
â¢ Retains all study records in accordance with sponsor requirements and University policies.
â¢ Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
â¢ Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
â¢ Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Code of Conduct.
â¢ Assists PI with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures.â¨Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.
â¢ Assists PI in submission of accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with Federal regulations and University and sponsoring agency policies and procedures.
â¢ Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.
â¢Coordinates appropriate and timely payments to participants (if applicable) in accordance with University policies and procedures.
The University of Southern California strongly values diversity and is committed to equal opportunity in employment.Â Women and men, and members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply.
Preferred Education: Bachelorâs Degree
Preferred Experience: 1-2 years
Language: English required. Spanish not necessary, but helpful.
Preferred Field of Expertise: Coordinator training, knowledge of medical environment and terminology
Percentage of Time: 100% FTE
Fixed Term: Â Â 1 yr Fixed Term
Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum educationMinimum Experience: 1 yearMinimum Field of Expertise: Administrative or research experience. Working knowledge of MS Office applications. Demonstrated effective communication and writing skills. Ability to multi-task and prioritize. Demonstrated ability to work as part of a team as well as independently.
Internal Number: REQ20092967
USC is the leading private research university in Los Angeles—a global center for arts, technology and international business. With more than 47,500 students, we are located primarily in Los Angeles but also in various US and global satellite locations. As the largest private employer in Los Angeles, responsible for $8 billion annually in economic activity in the region, we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills across a variety of academic and professional schools and administrative units. As a USC employee and member of the Trojan Family—the faculty, staff, students, and alumni who make USC a great place to work—you will enjoy excellent benefits, including a variety of well-being programs designed to help individuals achieve work-life balance.