About The Position

The Research Coordinator position assists investigators or other staff with research studies in subject recruitment, data collection, scheduling of study-related activities and follow-up of enrolled subjects.

Requirements

  • Bachelor’s Degree
  • Combined experience/education as substitute for minimum education.
  • 2 years 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.
  • Clinical documentation.
  • Communicate with others to gather information.
  • Understand and enforce regulatory guidelines.
  • Use database and/or word processing software.
  • Human Subjects Research (HSR) Training Certification from CITI Program.
  • Information Privacy Security (IPS) Research HIPAA 1 Basic -Certification from CITI Program.
  • Good Clinical Practice (GCP) Training Certification from CITI Program.

Nice To Haves

  • 2 years Knowledge of medical environment and terminology.
  • CCRC (Certified Clinical Research Coordinator) certification from ACRP.

Responsibilities

  • Assists with organizing and scheduling assessments/tests/activities to meet research objectives and study protocol compliance.
  • Communicates with study team personnel to ensure study procedures are followed and research is performed as described in protocol.
  • Serves as contact for subjects, study personnel, Institutional Review Board (IRB) and study sponsor.
  • Participates in assessing patient eligibility.
  • Assists in coordinating study participant activities including recruitment, screening, orientation and correspondence.
  • Schedules subject appointments, tests, and procedures coordinating with external providers as needed.
  • Produces reports and other materials, as directed.
  • Assists with data collection for research studies following established data collection and management procedures.
  • Collects, records, enters and prepares data for analysis.
  • Performs preliminary study analysis under the direction of the Principal Investigator or senior coordinators.
  • Collects pertinent information from study participants through interviews, administration of tests or surveys or questionnaires, medical records review, or other collection procedures.
  • Maintains accurate, complete and timely records, including source documents, consent forms, case report forms, protocol documents, and regulatory documents, as required by sponsor and institutional guidelines.
  • Assists in organization and preparation of grant proposals.
  • Gathers documentation such as annual reports and detailed budgets for inclusion in proposal.
  • Assists investigators in developing research proposals.
  • Interfaces with funding and regulatory agencies to exchange information.
  • Assists with submission of timely, accurate, and complete study continuing review, amendments, and reportable events to IRB.
  • Serves as regulatory coordinator for study sponsors and the IRB.
  • Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor and institutional regulations and policies.
  • Provides ongoing education to study subjects about clinical trials and provides significant new information that may affect a subject's willingness to participate in a study, when needed.
  • Evaluates subject compliance and promotes compliance through education.
  • Assists in the preparation of site for monitor visit and external/internal audits.
  • Provides timely response to queries from sponsor and/or auditors.
  • Collaborates with pharmacist or materials management personnel to maintain accurate accountability of investigational products and specimens.
  • Assists with sample collection, processing cmd shipment for each study.
  • Updates automated databases and other records for reporting and compliance purposes.
  • Generates reports and analysis of data according to project schedules or on an ad hoc basis.
  • Assists by arranging and attending meetings, seminars, symposia and other events related to project efforts.
  • Participates in educational opportunities to increase knowledge about clinical trials and regulations.
  • Remains current with federal, state, and institutional regulations and best practices.
  • Orders supplies and equipment.
  • Researches and develops recommendations for new equipment purchases.
  • Completes Research Order Form (ROF) for each subject visit and submits subject enrollment documentation as required.
  • Performs other related duties as assigned or requested.

Benefits

  • The University of Southern California Arcadia Hospital 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.
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