group
Category
Administrative Support
business
Department
Research Admin
date_range
Schedule
Per-Diem
schedule
Shift
Day
timer
Hours
8 Hour Shift
place
Location
Rancho Mirage, CA 92270
info
Job #
R0253411
  • Job Objective: A brief overview of the position.
    • This position is responsible for coordination and implementation of Sponsor Directed and EDCC directed Research Projects. Responsibilities include safety monitoring and data collection and recording. Coordinator Assistant will insure compliance with FDA regulations, sponsor guidelines and Clinical Trials Office Standard Operating Procedures. Basic understanding of safeguarding confidential information is essential. Proficiency in Word processing and spreadsheets is necessary. Excellent interpersonal skills, organizational skills, accuracy, ability to meet timelines and attention to detail are requisite.
  • Reports to
    • Supervisor, Ancillary Testing
  • Supervises
    • None
  • Ages of Patients
    • Adolescent
    • Adult
    • Geriatric
  • Blood Borne Pathogens
    • Minimal/ No Potential
  • Qualifications
    • Education
      • Preferred: Bachelor of Science – emphasis in Physiology, Biology
    • Licensure/Certification
      • Preferred: ACRP Certification
    • Experience
      • Required: Medical Assistant or Medically related or Research Experience. 1 year experience in Health/Research Environment
      • Preferred: Previous experience with clinical trials.
  • Essential Responsibilities
    • Demonstrates compliance with Code of Conduct and compliance policies and takes action to resolve compliance questions or concerns and report suspected violations.
    • Participates in the complete design, planning and conduct process of clinical research projects, including:
      • Performing periodic monitoring visits to assure that the protocol, obligations, responsibilities and regulations are established and followed.
      • Monitors subject records for quality, data integrity and compliance with regulations and organization’s SOP’s.
      • Assists in writing and/or auditing clinical reports.
      • Works closely with Contract Research Organization (CRO) and other study sponsors staff members.
      • Coordinates patient scheduling between research office and clinical sites.
      • Manages clinical site activities (regulatory issues, patient accrual, data capture and monitoring, adverse events reporting).
      • Acts as liaison between sites, CRO and other departments. Attends to study meetings organized by sponsors, generally at sponsor site, as applicable.
      • Develops sufficient product/indication expertise to communicate directly with clinicians, staff, other departments, consultants, etc.
      • Assists in tracking and reporting Serious Adverse Events to sites, sponsor.
    • Works closely with community based physicians and staff to facilitate research and enrollment to trials.
    • Maintains knowledge of data management of IDE’s being utilized.
    • Develops and maintains a formal mechanism to ensure that information about the availability of related clinical trails is provided to patients.
    • Works with Community Outreach to develop education/promotional materials to educate patients on available clinical trials.
    • Works to accrue and monitor cases enrolled in clinical trials.
    • Coordinates performance improvement activities as they relate to research and clinical trails.
    • Review subject charts and other sources to screen and identify potential subjects for inclusion in study, based on protocol criteria.
    • Maintain inventory log of study drugs/services.
    • Obtain and handle subject biologicals for protocol.
    • Provides administrative support to physicians and EMC IRB and tracks EDCC Cardiac Trials.
    • Performs other duties as assigned.
       

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