Research Coordinator I

Keck Medicine of USC•Los Angeles, CA

1d•Onsite

About The Position

This is a full-time, fully on-site position that supports the USC Mark and Mary Stevens Center for Orthobiologics. The Research Coordinator will assist faculty with research studies. Essential duties and responsibilities include screening eligible patients for data and sample collections, engaging in patient outreach for consent collection, and collaborating with the clinical team regarding study enrollment and/or data and sample collection. The role involves transporting collected samples to and from clinic sites to the lab for processing, ongoing data collection and management of related databases, and managing requests for specimens according to IRB approval. The position also assists in the preparation of IRB applications and completes various administrative ad hoc tasks and projects. It aids in organizing and scheduling assessments/tests/activities to meet research objectives and study protocol compliance, and communicates with study team personnel to ensure study procedures are followed and research is performed as described in the protocol. The Research Coordinator serves as a contact for subjects, the Institutional Review Board (IRB), and the study sponsor, and participates in assessing patient eligibility. They assist in coordinating study participant activities including recruitment, screening, orientation, and correspondence, and schedule subject appointments, tests, and procedures, coordinating with external providers as needed. The role produces reports and other materials as directed, assists with data collection for research studies following established data collection and management procedures, and performs preliminary study analysis under the direction of the Principal Investigator or senior coordinators. Responsibilities also include collecting pertinent information from study participants through interviews, administration of tests or surveys or questionnaires, medical records review, or other collection procedures, and maintaining 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. The position assists with the submission of timely, accurate, and complete study continuing review, amendments, and reportable events to the IRB, and ensures the consent process is performed and documented in compliance with regulations and policies. It 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. The role assists in the preparation of the site for monitor visits and external/internal audits, and assists with sample collection, processing, and shipment for each study. Updates automated databases and other records for reporting and compliance purposes, and generates reports and analysis of data according to project schedules are also key duties. The position assists by arranging and attending meetings, seminars, symposia, and other events related to project efforts, and participates in educational opportunities to increase knowledge about clinical trials and regulations, remaining current with federal, state, and institutional regulations and best practices. Finally, the role orders supplies and equipment, researches and develops recommendations for new equipment purchases, and completes Research Order Forms (ROF) for each subject visit and submits subject enrollment documentation as required. The position follows established USC and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.

Requirements

Bachelor's degree, Combined experience/education as substitute for minimum education
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.

Responsibilities

Screening eligible patients for data and sample collections.
Engage in patient outreach for consent collection.
Collaborate with clinical team regarding study enrollment and/or data and sample collection.
Transport of collected samples to and from clinics cites to the lab for processing.
Ongoing data collection and management of related databases.
Manage request of the specimens according to IRB approval.
Assist in preparation of IRB applications.
Complete various administrative ad hoc tasks and projects.
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, 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.
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 with submission of timely, accurate, and complete study continuing review, amendments, and reportable events to IRB.
Ensures consent process is performed and documented in compliance with 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.
Assists in the preparation of site for monitor visit and external/internal audits.
Assists with sample collection, processing and 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.
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.
Follows established USC and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.