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Certified Medical Assistant For Clinical Research

Company

IQVIA
Address , Sacramento
Employment type FULL_TIME
Salary $64,300 - $80,400 a year
Expires 2023-09-21
Posted at 8 months ago
Job Description

Job Overview
Coordinate and execute activities related to the Investigational Product (IP). Participate in clinical research studies ensuring that clinical trial tasks are carried out according to protocol, contracted scope of work, good clinical practice, sponsor and Avacare standard operating procedures (SOPs) and any relevant local guidelines and regulations.

Essential Functions
  • Maintains source documentation based on protocol requirements that adhere to Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) documentation principles
  • Record and maintain appropriate temperature of the IP per study protocol
  • Adheres to standard operating procedures (SOPs) and other directives throughout this process
  • Participates in study process reviews and enhancement efforts to support control of site unit budget, development of the research facilities and site services and the culture towards a high performing research study team
  • Complete all required sponsor training
  • Maintain responsibility for the management of inventory/IP accountability: i.e., orders, replacements, return of IP study materials
  • Reports any deviations from normal research practices to senior staff and implement agreed changes in the study care program
  • Updates and maintains site staff skills, training and knowledge of current best nursing practices and topics related to clinical research
  • Assists research site with coverage planning related to staffing and scheduling for research projects
  • Corresponds with research subjects to troubleshoot study-related questions or concerns
  • Ensure appropriate receipts of all investigational product
  • Maintains a safe environment in accordance with site policies
  • Provides guidance and supervision to lower-level site staff to help provide that processes are carried out in line with protocols and SOP's, where applicable
  • Actively involved in study data quality checking and query resolution
  • Assists the investigators to safeguard the well-being of subjects and maintain standards required of clinical research sites
  • Provides clinical research support to investigators to prepare for and execute all tasks related to the investigational product
  • Participates in routine meetings with site study staff and Investigators to confirm study tasks are assigned and are executed to the expected standards
  • Follow and maintain all blinding procedures with study volunteers and blinded team members
  • Preparation and administration of IP to clinical research patients
  • Reviews study protocols and study documents and instructions related to the investigational product
  • Assists investigator in verifying that research study objectives are met on time, within budget and according to application protocol requirements, clinical research regulations and quality standards
  • Assists in providing training to new investigator site staff members on study-specific topics and requirements
  • Prepares for and attend study monitoring visits, study audits and regulatory inspections with clinical research regulatory agencies
Qualifications
  • Certified Medical Assistant
  • Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  • Basic knowledge of medical terminology
  • Ability to maintain confidentiality.
  • Excellent patient care experience
  • Proficient in the use of technology
  • 2+ years’ experience administering vaccines

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Colorado/California/Washington state Pay Transparency : The salary range for this role is $64,300 - $80,400.The actual salary will vary based on factors like candidate qualifications and competencies. Certain roles are eligible for annual bonus, sales incentives and/or stock. Benefits may include healthcare, retirement, paid time off, and more.