Job Description

Job Description

Job Title: Clinical Research Coordinator II

Location: Los Angeles, CA 90033

Duration: 6+ Months (High Possibility of extension)

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, Institutional Review Board (IRB) and study sponsor.
• Participates in assessing patient eligibility.
• Assists in 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 assists in organization and preparation of grant proposals.
• Gathers documentation such as annual reports and detailed budgets for inclusion in proposal.
• May assists 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 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 and shipment for each study as needed.
• 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 enrolment 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 Advance.
• 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 multi-task.
• 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

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