Website Apolis
Apolis
Company : Apolis
Job title: Clinical Research Coordinator
Job Location: Los Angeles, CA 90033
Job Duration: 6 months – Temp to hire for right fit
Pay Rate – $32/hr. on W2
Shift: Monday-Friday 8am-5pm (8hours).
1-2 days remote with additional days on-site as needed
Job Summary:
- 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 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 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