Site Administrator

The Site Administrator is an integral part of the SEO Operations team and supports the daily operations of clinical trials by assisting in data collection/entry patient interactions (i.e. scheduling and patient flow) and compliance with study protocols. Study-specific delegated tasks will be determined by the Principal Investigator 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:

• Assist with the coordination and execution of clinical research studies in compliance with protocols and research regulations.
• Screen and recruit study participants under the guidance of the site coordinator.
• Collect and record patient data accurately including medical history; collect and prepare lab specimens for local or central lab processing; and distribute laboratory and study-related results for investigator review in a timely manner.
• Assist in scheduling participant visits coordinating appointments and follow-ups.
• Monitor study participants for adverse events and report any issues to the research team.
• Maintain accurate and up-to-date study documentation including case report forms (CRFs) and patient records.
• Maintain appropriate records of investigational product receipt dispensation and return.  Ensure records are current accurate and legible at all times.
• 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 Site Coordinator (local level) and administratively 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. The scope of the Site Administrators responsibilities will be clearly defined for each site before placement. The Site Administrator is responsible for providing services as assigned and should consult the Milestone One manager assigned for any questions. 

Qualifications :

Education

High school degree or equivalent

Certifications

• Current Good Clinical Practice (GCP) may be obtained during orientation
• International Air Transport Association (IATA) may be obtained during orientation
• Cardiopulmonary Resuscitation (CPR) may be obtained during orientation
• Phlebotomy certification (preferred).

Experience

Experienced in a medical office or hospital setting for at least 1 year must demonstrate medical terminology proficiency.

Knowledge & Skills

• 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 drivers license

Behavioral Skills

• Excellent communications skills
• Attention to detail
• Effective problem-solving and result-oriented
• Accountability
• Team player

Trainings

• Induction training in SOPs and admin practices for Site Administrator
• On-the-job training under the supervision of the SEO Manager or designated person

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Remote Work :

Yes

Employment Type :

Full-time