Site Management Associate II

JobsInSAS.com; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

PSI CRO in Austin, Texas is seeking a Site Management Associate II to support site operations, regulatory submissions, and document control for multisite clinical trials. The role focuses on streamlining communication, maintaining systems and managing site records.

You will coordinate with vendors, monitors and internal teams to ensure timely completion of TMF checks and audits. Ideal candidates have a college degree, 2 years of clinical research admin experience, and basic MS Office

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.
• 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

Skills

Typing 40 wpm

Education

College or university degree

Equivalent combination of education, training and experience

Tools

MS Word

MS Excel

MS Outlook

MS PowerPoint

Job description

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

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Site Management Associate II

PSI CRO

• Full-time
• Austin, Texas, United States
• 6d ago

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Start your career in clinical research, streamlining communication, maintaining systems and managing documents.

The Scope Of Responsibilities Will Include

• 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

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)

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

PSI CRO