Research Coordinator I

USC's Keck School of Medicine, Department of Medicine, is seeking a Research Coordinator I to join its Cardiology team. The Research Coordinator's role is to support, facilitate and coordinate the daily activities of clinical research in Cardiology. The Research Coordinator works with and under the supervision of the Director of the Clinical Research Program and 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:

• General Administrative
• 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
• Collaborates with the PI to prepare IRB and any other regulatory submission documents.
• Prepares other study materials as requested by the PI. These study materials include, but are not limited to, informed consent documents, case report forms (CRFs), enrollment logs, and data collection forms.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
• Conduct of Research
• Reviews and develops knowledge of the protocol, e.g. timelines, inclusion/exclusion criteria, confidentiality, privacy protections.
• Assists in communication of study requirements to all individuals involved in the study.
• Collects documents needed to initiate study and submit to sponsor (ie FDA Forms, CVs, etc)
• Assists in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Assures that amended consent forms are appropriately implemented and signed.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
• Registers participants to the appropriate coordinating center
• Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
• Coordinates participant tests and procedures.
• Collects data as required by the protocol and completes Case Report Forms.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and USC Investigational Drug/Device Accountability.
• Retains all study records in accordance with sponsor requirements and University policies.
• Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
• Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
• Reporting
• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Code of Conduct.
• Assists PI with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures. Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.
• + Project Closeout
• 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.
• Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.
• + Financial Management
• Coordinates appropriate and timely payments to participants (if applicable) in accordance with University policies and procedures.

Hourly range:

The hourly rate range for this position is $32.01 - $35.00. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 1 year Minimum 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.