Site Management Associate II
About the role
The Site Management Associate II plays a crucial role in the smooth operation of clinical trials, serving as the primary point of contact for non-trial participant related matters and coordinating various administrative tasks.
Responsibilities
- Main site contact for all non-trial participant related and non-protocol related issues, including vendors, trial supplies and access management
- Manages records flow with sites and off-site facilities
- Prepares regulatory and ethics committee submission/notification documents and records
- Captures and coordinates payments to sites and off-site facilities
- Coordinates and follows up on site audits and inspections
- Reviews and coordinates site-specific query resolution with monitors and sites
- Reviews site-specific EDC completion progress and provides the monitor with regular updates
- Serves as the main contact point for other company departments in administrative site-related issues
- Organizes, participates in, and prepares reports of internal project team meetings
- Collaborates with sites and project team on investigator meetings' organization
- Under supervision, provides on-the-job coaching of Site Management Associates I and Clinical Operations Administrative Support staff
- Arranges and tracks initial and ongoing trial training for investigator site teams in all vendor-related systems
- Provides training in courier management and trial supplies ordering to the investigator sites
- Fills trial records in the TMF and performs regular TMF checks on a site and country level
- Participates in and follows up on TMF and systems audits
- Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
- Coordinates the translation process for trial records on a site and country level
- Collects IP-REDs and compiles IP-RED packages for further review
Qualifications
- College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient
- Minimum 2 years of experience within the clinical research industry, corporate or academic environment where administrative experience and technical skills have been gained
- Basic proficiency in MS Word
- Basic proficiency in MS Excel
- Basic proficiency in MS Outlook
- Basic proficiency in MS PowerPoint
- Knowledge (following proper training) of applicable software and project specific systems
- Basic typing skills in English (min. 40 words per minute)
Benefits
Join the company that focuses on its people and invests in their professional development and success.
Pay
Details on pay are not specified in the posted job description.
Schedule
Details on schedule are not specified in the posted job description.
Skills
Not specified in the posted job description.
Benefits
Details on benefits are not specified in the posted job description.
Pay
Details on pay are not specified in the posted job description.
Schedule
Details on schedule are not specified in the posted job description.
Skills
Not specified in the posted job description.
Benefits
Details on benefits are not specified in the posted job description.
Pay
Details on pay are not specified in the posted job description.
Schedule
Details on schedule are not specified in the posted job description.
Skills
Not specified in the posted job description.
Benefits
Details on benefits are not specified in the posted job description.