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
Job Tags
Weekend work,