group
Category
Specialists (Clinical and Non-Clinical)
business
Department
Research Admin
date_range
Schedule
Full Time
schedule
Shift
Varies
timer
Hours
8 Hour Shift
place
Location
Rancho Mirage, CA 92270
info
Job #
R0254496
  • Job Objective: A brief overview of the position.
    • Responsible for coordination and implementation of clinical research activities.
  • Reports to
    • Director, Research Administration
  • Supervises
    • None
  • Ages of Patients
    • Adult
    • Geriatric
  • Blood Borne Pathogens
    • Minimal/No Potential
  • Qualifications
    • Education
      • Required: Bachelors degree in healthcare and/or related field.
      • Preferred: Masters degree
    • Licensure/Certification
      • Required: Completion of CITIProgram courses: CITI Good Clinical Practice Course and Study Coordinator/Study Staff
      • Preferred: ACRP CCRC or SOCRA CCRP Certification. Certification required upon eligibility.
    • Experience
      • Required: Three (3) years current experience in acute care hospital, medical center or health system.
      • 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.
    • Recruit, educate, consent, schedule, and complete follow-up with patients/subjects.
    • Participate in the design, planning & conduct of lung screening program and clinical research projects.
    • Perform pre-investigation, initiation & periodic monitoring visits to assure that the protocol, obligations, responsibilities, and regulations are established & followed.
    • Monitor subject records for quality, data integrity, & compliance with regulations and organization’s SOPs.
    • Assist in writing and/or auditing clinical reports.
    • Assist in developing protocols, case report forms, and informed consent documents.
    • Work closely with sponsors and Contract Research Organization (CRO) staff members.
    • Assist with negotiation & monitoring of budgets and contracts.
    • Coordinate patient scheduling.
    • Perform clinical site activities (regulatory issues, patient accrual, data capture & monitoring, adverse events reporting).
    • Act as liaison between sponsor, sites, CRO, and other departments. 
    • Develop sufficient service/ program / product / indication expertise to communicate directly with clinicians, staff, other departments, consultants etc.
    • Assist in tracking & reporting Serious Adverse Events.
    • Work with physicians & leadership to develop & implement lung screening and research programs.
    • Coordinate participation with I-ELCAP and other sponsors as necessary.
    • Work closely with community based physicians and staff to facilitate research and enrollment to lung screening program and trials.
    • Prepare and present materials to Institutional Review Board (IRB).
    • Data Management – knowledge of computer systems to support entry of case report forms.
    • Develop & maintain a formal mechanism to ensure that information about the availability of clinical trials is provided to patients.
    • Work with Community Outreach to develop educational/promotional materials to educate patients on available programs and clinical trials.
    • Work to accrue and monitor cases enrolled in program and clinical trials; report to governing Committee.
    • Coordinate performance improvement activities as they relate to lung screening program and research.
    • Monitor budget for program and clinical trials.
    • Provides administrative support to investigators and maintain screening, enrollment, compliance, statistics on program and trials.
    • Develops and implements Education Program for the community, including materials and lectures.
    • Performs other duties as assigned.