Job description
Company Description
We are a fast-growing Site Enabling Organization operating globally in the field of clinical research. We are driven by quality, teamwork, and innovation. As we continue to expand our global operations, we are seeking a passionate and dedicated Site Administrator to join our Operations Team.
Job Description
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 Research Assistant reports to the Site Coordinator (local level) and administratively to the Milestone One Manager responsible for the region. Within clinical trials, the Research Assistant 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 Research Assistant’s responsibilities will be clearly defined for each site before placement. The Research Assistant 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 driver’s 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 Research Assistant
- 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.
