Research Coordinator - Clinical Research Institute - Full Time 8 Hours Day (Non-Union, Non-Exempt)

JOB ACCOUNTABILITIES

• 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. And 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. The university reserves the right to add or change duties at any time.

Education
Req
Bachelor’s Degree Combined experience/education as substitute for
minimum education.

Work Experience
Req
2 years Administrative or research experience.
Working knowledge of MS Office applications.

Pref

2 years Knowledge of medical environment and terminology.

Knowledge, Skills and Abilities
Req
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.

Licenses/Certifications
Req
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.

Pref

CCRC (Certified Clinical Research Coordinator) certification from
ACRP.

Pay Transparency

The hourly rate range for this position is $34.32 - $56.19. When extending an offer of employment, the University of Southern California Arcadia Hospital considers fact