University of Southern California

Research university in Los Angeles, CA

Research Coordinator

Clinical Research OperationsUpdated on Nov 13

Part-timeArcadia, CA, USA$34.32 - $56.19 /hrIn-person

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 both 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 procedures are followed and research is conducted 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 coordinate participant recruitment, screening, orientation, correspondence, appointments, tests, and procedures, including coordination with external providers as needed; produce reports and other materials as directed.
Assist with data collection for research studies according to 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 participant information through interviews, tests, surveys, questionnaires, medical-record reviews, or other procedures.
Maintain accurate, complete, and timely records, including 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, assist investigators in developing proposals, and exchange information with funding and regulatory agencies.
Submit timely, accurate, and complete continuing reviews, amendments, and reportable events to the IRB; serve as regulatory coordinator for study sponsors and the IRB.
Ensure the consent process is performed and documented in compliance with FDA, Good Clinical Practice (GCP), IRB, HIPAA, standard operating procedures (SOPs), sponsor requirements, and institutional regulations and policies.
Educate study subjects about clinical trials, provide significant new information that may affect willingness to participate, evaluate subject compliance, and promote compliance through education.
Assist with site preparation for monitor visits and external or internal audits; 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; generate reports and data analyses according to project schedules or on an ad hoc basis.
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; 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 by the university.

Desired Qualifications

Two years of knowledge of the medical environment and terminology.
Certified Clinical Research Coordinator (CCRC) certification from the Association of Clinical Research Professionals (ACRP).

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 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.

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.

USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to theBackground Screening Policy Appendix Dfor specific employment screen implications for the position for which you are applying.

We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at (213) 821-8100, or by email at [email protected]. Inquiries will be treated as confidential to the extent permitted by law.

If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser:

https://wd5.myworkday.com/usc/d/inst/1$9925/9925$154609.htmld

About the Company

University of Southern California

Research university in Los Angeles, CA

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.

Company size: Not listed
Company stage: Not listed
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