Site Administrator

PSI CRO

6h•Remote

About The Position

The Site Administrator is an integral part of the SEO Operations team and supports the daily operations of clinical trials, supporting onsite and remote Milestone One staff as assigned. Study-specific delegated tasks will be determined by the Principal Investigator (if applicable), considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. In addition, administrative tasks may be assigned by the Milestone One Manager. In this job you will: Support the connection between sponsors and/or CROs with appropriate studies and clinical research sites, contributing to study start-up and site selection processes. Responsibilities will include providing study site identification support, assisting with the organization and coordination of feasibility-related information, and contributing to process organization and documentation to support operational efficiency. Additionally, you may also be asked to assist with the coordination and execution of clinical research studies in compliance with protocols and research regulations. Assist with data entry of clinical trial information as assigned. Assist in scheduling participant visits, coordinating appointments, and follow-ups. Maintain accurate and up-to-date study documentation, including staff credentials and regulatory files. Must be effectively communicate with onsite staff regarding updated documents that impact study data. Maintain files for SOP’s and other internal files as delegated. Ensure all study activities follow Good Clinical Practice (GCP) guidelines and institutional review board (IRB) requirements. Prepare and organize study materials, equipment, and supplies. Support the research team in compiling reports and preparing data for analysis. Attend study meetings and training sessions as required. The Site Administrator reports to the Milestone One Manager responsible for the region. Within clinical trials, the Site Administrator reports to the individual Principal Investigator by the responsibilities as delegated on the delegation of authority log for each clinical trial (if applicable). The scope of the Site Administrator’s responsibilities will be clearly defined for each project. The Site Administrator is responsible for providing services as assigned and should consult the Milestone One manager assigned for any questions.

Requirements

High school degree or equivalent
Current Good Clinical Practice (GCP) may be obtained during orientation
International Air Transport Association (IATA) if required, may be obtained during orientation
Cardiopulmonary Resuscitation (CPR) if required, may be obtained during orientation
Experienced in a clinical research setting for at least 1 year. Must demonstrate clinical research and general medical terminology proficiency.
Proven experience conducting site feasibility assessments, including the ability to develop and execute strategies for identifying study opportunities across multiple therapeutic areas.
Must have experience with initial IRB submission and maintenance requirements and procedures.
Interested in clinical research and healthcare.
Strong organizational and time-management skills.
Attention to detail and the ability to interpret and implement protocol and guidelines.
Proficiency in MS Office
Valid category B driver’s license
Excellent communications skills
Attention to detail
Effective problem-solving and result-oriented
Accountability
Team player

Responsibilities

Support the connection between sponsors and/or CROs with appropriate studies and clinical research sites, contributing to study start-up and site selection processes.
Responsibilities will include providing study site identification support, assisting with the organization and coordination of feasibility-related information, and contributing to process organization and documentation to support operational efficiency.
Assist with data entry of clinical trial information as assigned.
Assist in scheduling participant visits, coordinating appointments, and follow-ups.
Maintain accurate and up-to-date study documentation, including staff credentials and regulatory files. Must be effectively communicate with onsite staff regarding updated documents that impact study data.
Maintain files for SOP’s and other internal files as delegated.
Ensure all study activities follow Good Clinical Practice (GCP) guidelines and institutional review board (IRB) requirements.
Prepare and organize study materials, equipment, and supplies.
Support the research team in compiling reports and preparing data for analysis.
Attend study meetings and training sessions as required.