Applicants will only be eligible to proceed with the hiring process if the applicant: (1) is fully vaccinated and can provide proof of vaccination; or (2) qualifies for a medical or religious exemption that can be accommodated by Eisenhower Health.

group
Category
Specialists (Clinical and Non-Clinical)
business
Department
Research-Neurology
date_range
Schedule
Full Time
schedule
Shift
Varies
timer
Hours
8 Hour Shift
place
Location
Rancho Mirage, CA 92270
info
Job #
R0260357
  • Job Objective: A brief overview of the position.
    • Responsible for coordination and implementation of clinical research activities. Coordinates and quality controls the development and maintenance of clinical research studies, ensuring compliance with IRB requirements and all related laws, regulations, policies, and guidelines. Provides day-to-day technical leadership and support to associates engaged in the execution of multiple, complex research protocols. Provides administrative assistance of the research activity and participates in the formulation and implementation of operating strategies and policies, protocols, systems, and procedures
  • Reports to
    • Manager, Research and Clinical Trials
  • Supervises
    • Non-exempt research staff
  • 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 CITI Good Clinical Practice (GCP) for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course (www.CITIprogram.org)
      • Required: SOCRA or ACRP certification upon eligibility
      • Preferred: ACRP or SOCRA certification
    • Experience
      • Required: Three (3) years current experience in medical center, research institute and/or Biotech/CRO
      • 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.
    • Participate in the training and supervision of research staff; provide research staff with protocols and guidance on SOPs to ensure consistency and compliance with policies and processes.
    • Supervise the day-to-day activities of team members to ensure efficient and compliant operations.
    • As needed, recruit, educate, consent, schedule, and complete follow-up with patients/subjects.
    • Participate in the design, planning and conduct of clinical trial protocols and research projects. Assist in developing protocols, case report forms, and informed consent documents.
    • Perform pre-investigation, feasibility analysis, site selection, study initiation and periodic monitoring visits to ensure that the protocol, obligations, responsibilities, and regulations are established and followed.
    • Monitor subject records for quality, data integrity, and compliance with regulations and organization’s SOPs.
    • Assist in writing and/or auditing clinical reports.
    • Work closely with sponsors and Contract Research Organization (CRO) staff members to prepare data for analysis, monitoring visits and audits.
    • Assist with negotiation and monitoring of budgets and contracts.
    • Coordinate patient scheduling.
    • Perform clinical site activities (regulatory issues, patient accrual, data capture and monitoring, adverse event reporting).
    • Act as liaison among sponsor, sites, CRO, and other departments. Coordinate with onsite personnel to implement research needs: e.g., technical support for remote audits and electronic source maintenance; infusion of Investigation New Drugs (INDs); research specimens; labs; and image transmission.
    • Develop sufficient service/ program / product / diagnosis expertise to communicate directly with clinicians, staff, other departments, consultants, etc.
    • Assist in tracking and reporting Serious Adverse Events.
    • Work with physicians and leadership to develop and implement clinical trials and research programs.
    • Work closely with physicians and staff to facilitate research and enrollment to clinical trials.
    • Provide support to research staff and investigators to prepare and present materials to Institutional Review Board (IRB).
    • Data Management – Monitor and assist in data collection and reporting. Keep track of and resolve queries in a timely manner. Maintain knowledge of computer systems to support entry of case report forms.
    • Develop and 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 research, including corrective and preventive action plans (CAPAs) to improve data quality and regulatory compliance and reduce queries, deviations and violations.
    • Monitor budget for program and clinical trials.
    • Provide support to leadership and investigators and maintain screening, enrollment, compliance, and statistics on program and trials.
    • Develop and implement education program for the community, including materials and lectures.
    • Perform other duties as assigned.