Site Management Associate II: Clinical Operations & Compliance

Psi-Cro; Austin (TX); On-site; USD 52,000 - 65,000; Full time

Job summary

Psi-Cro is seeking an Administrative/Site Operations Support professional in Austin, TX to streamline communication, maintain systems and manage documents within a clinical research setting.

You will act as the main site contact for non-trial-participant issues, coordinate with vendors, manage records flow, prepare submissions, and support audits and training across investigator sites and country level operations.

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 year 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 Power Point.
• Knowledge (following proper training) of applicable software and project specific systems.
• Basic typing skills in English (min. 40 words per minute)

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
• Coordinates payments to sites and off-site facilities
• Prepares for 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
• Files 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

Skills

Administrative coordination

Communication

Organizational skills

Time management

Education

Bachelor's degree or equivalent

Tools

MS Word

MS Excel

MS Outlook

MS PowerPoint

Job description

Psi-Cro is seeking an Administrative/Site Operations Support professional in Austin, TX to streamline communication, maintain systems and manage documents within a clinical research setting.

You will act as the main site contact for non-trial-participant issues, coordinate with vendors, manage records flow, prepare submissions, and support audits and training across investigator sites and country level operations.