Clinical Research Coordinator II

 Job Title: Clinical Research Coordinator
Location: Los Angeles, CA
Hybrid, 1-2 days remote with additional days on-site as needed
Duration of Assignment: 6 months
Shift: Monday-Friday 8am-5pm (8hours).
Dress code: Business casual
Laptop/Equipment: Provided by dept/CTSI
 

Key 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 the study protocol.
• Serves as contact for subjects, study personnel, the Institutional Review Board (IRB), and the study sponsor.
• Participates in assessing patient eligibility.
• Assists in the coordination of 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, 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.
• May assist in the organization and preparation of grant proposals.
• Gathers documentation such as annual reports and detailed budgets for inclusion in the proposal.
• May assist investigators in developing research proposals.
• Can interface 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.
• Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor, and institutional regulations and policies.
• Provides ongoing education on 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 the site for monitor visits and external/internal audits.
• Provides timely response to queries from the 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, and shipment for each study as needed.
• Updates automated databases and other records for reporting and compliance purposes.
• Generates reports and analyses 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.

 Required Qualifications:

• Bachelor’s degree (or combined experience/education as substitute for minimum education).
• Prior clinical research experience of 1+ years.
• Knowledge of medical environment and terminology.
• Bilingual Spanish/English Skill Level: Fluent or Advanced.
• Proficient with MS Office applications.
• Strong communication skills (written and oral).
• Attention to detail.
• Highly skilled and organized.
• Demonstrates ability to work as part of a team as well as independently.
• Ability to multitask.
• Demonstrated effective communication and writing skills.
• Willingness to work afternoons and weekends.

 Preferred Qualifications (above plus those below):

• Regulatory experience both for industry and federally-funded studies (IRB initial application submissions, amendments, continuing reviews)
• Certified/Licensed Phlebotomist
• Knowledge and understanding of federal, state, and institutional research regulations as well as Good Clinical Practices (GCP) and HIPAA regulations.
• Knowledge of Oncore CTMS
• Knowledge of iStar regulatory system
• Phlebotomy

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $32.00/hr.