U

University of Southern California

Research university in Los Angeles, CA

Research Coordinator - Clinical Research Institute

Part-Time
$34.32 - $56.19/hr
Mid
Bachelor's
Arcadia, CA, USA
In Person
Biology & BiotechClinical Research Operations

About the job

Requirements
  • A bachelor's degree is required, although combined experience and education may substitute for the minimum education requirement.
  • Two years of administrative or research experience are required.
  • Working knowledge of Microsoft Office applications is required.
  • Demonstrated effective communication and writing skills are required.
  • Ability to multitask and prioritize is required.
  • Ability to work as part of a team and independently is required.
  • Clinical documentation skills are required.
  • Ability to communicate with others to gather information is required.
  • Ability to understand and enforce regulatory guidelines is required.
  • Ability to use database and/or word-processing software is required.
  • Human Subjects Research (HSR) Training Certification from the CITI Program is required.
  • Information Privacy Security (IPS) Research HIPAA 1 Basic Certification from the CITI Program is required.
  • Good Clinical Practice (GCP) Training Certification from the CITI Program is required.
Responsibilities
  • Organize and schedule assessments, tests, and activities to meet research objectives and comply with study protocols.
  • Communicate with study team personnel to ensure study procedures are followed and research is performed as described in the protocol; serve as a contact for subjects, study personnel, the Institutional Review Board (IRB), and study sponsors.
  • Participate in assessing patient eligibility and assist with coordinating participant recruitment, screening, orientation, correspondence, appointments, tests, and procedures, coordinating with external providers as needed.
  • Produce reports and other materials as directed.
  • Assist with data collection for research studies using established collection and management procedures; collect, record, enter, and prepare data for analysis.
  • Perform preliminary study analysis under the direction of the Principal Investigator or senior coordinators.
  • Collect information from study participants through interviews, tests, surveys or questionnaires, medical-record reviews, and other collection procedures.
  • Maintain accurate, complete, and timely source documents, consent forms, case report forms, protocol documents, and regulatory documents in accordance with sponsor and institutional guidelines.
  • Assist with organizing and preparing grant proposals, gather supporting documentation such as annual reports and detailed budgets, and assist investigators in developing research proposals.
  • Interface with funding and regulatory agencies to exchange information.
  • Assist with timely, accurate, and complete submissions to the IRB for continuing reviews, amendments, and reportable events; serve as regulatory coordinator for study sponsors and the IRB.
  • Ensure that informed consent is performed and documented in compliance with FDA, GCP, IRB, HIPAA, standard operating procedures, sponsor requirements, and institutional regulations and policies.
  • Provide ongoing education to study subjects about clinical trials and new information that may affect their willingness to participate; evaluate subject compliance and promote compliance through education.
  • Assist with site preparation for monitor visits and external or internal audits, and respond promptly to sponsor and auditor queries.
  • Collaborate with pharmacists or materials management personnel to maintain accurate accountability of investigational products and specimens.
  • Assist with sample collection, processing, and shipment for each study.
  • Update automated databases and other records for reporting and compliance, and generate reports and data analyses according to project schedules or as needed.
  • Arrange and attend meetings, seminars, symposia, and other events related to project efforts.
  • Participate in educational opportunities to increase knowledge of clinical trials and regulations, and remain current with federal, state, and institutional regulations and best practices.
  • Order supplies and equipment, and research and develop recommendations for new equipment purchases.
  • Complete a Research Order Form (ROF) for each subject visit and submit subject enrollment documentation as required.
  • Perform other related duties as assigned or requested; duties may be added or changed.
Desired Qualifications
  • Two years of knowledge of the medical environment and terminology are preferred.
  • Certified Clinical Research Coordinator (CCRC) certification from the Association of Clinical Research Professionals (ACRP) is preferred.

About the company

U

University of Southern California

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The University of Southern California is a private research university with academic programs across the arts, sciences, business, engineering, law, health, and other professional fields.

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