Certified Medical Assistant for Clinical Research

IQVIA Holdings Inc.

Sacramento, California, United States

Job OverviewCoordinate 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•  Provides clinical research support to investigators to prepare for and execute all tasks related to the investigational product• Reviews study protocols and study documents and instructions related to the investigational product• Complete all required sponsor training• Follow and maintain all blinding procedures with study volunteers and blinded team members• Ensure appropriate receipts of all investigational product• Maintains source documentation based on protocol requirements that adhere to Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) documentation principles• Maintain responsibility for the management of inventory/IP accountability: i.e., orders, replacements, return of IP study materials• Record and maintain appropriate temperature of the IP per study protocol• Preparation and administration of IP to clinical research patients• Corresponds with research subjects to troubleshoot study-related questions or concerns• Participates in routine meetings with site study staff and Investigators to confirm study tasks are assigned and are executed to the expected standards• Actively involved in study data quality checking and query resolution• Updates and maintains site staff skills, training and knowledge of current best nursing practices and topics related to clinical research• Assists the investigators to safeguard the well-being of subjects and maintain standards required of clinical research sites• Maintains a safe environment in accordance with site policies• Reports any deviations from normal research practices to senior staff and implement agreed changes in the study care program• 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• 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• 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• Prepares for and attend study monitoring visits, study audits and regulatory inspections with clinical research regulatory agencies• Adheres to standard operating procedures (SOPs) and other directives throughout this process• Assists research site with coverage planning related to staffing and scheduling for research projects

Qualifications• Certified Medical Assistant• 2+ years’ experience administering vaccines • Excellent patient care experience • Basic knowledge of medical terminology• Proficient in the use of technology• Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.• Ability to maintain confidentiality.• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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.  https://

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.

The potential base pay range for this role, when annualized, is $64,300.00 - $96,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Job posted: 2023-11-15

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