Senior Site Management Associate

Job Description

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 & II 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

• Main vendor contact for all non-trial participant related issues, including pre-trial testing of vendor systems

• Tracks vendor-related supplies on a site, country/regional level

• Exchanges information and records with vendors

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 3-year experience within the clinical research industry, CRO preferred, in similar role or equivalent to Site Management Associate II

• 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.

Additional Information

Become a full-fledged clinical research professional with the support of a knowledgeable and professional team. You will develop a variety of skills while progressing with the company and contributing to our full-scale challenging projects.

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