Site Management Associate II

PSI CRO; Pennsylvania; On-site; USD 60,000 - 85,000; Full time

Job summary

PSI CRO is seeking a Site Management Associate to act as the main site contact for non-trial related issues and manage documentation across trial processes. The role involves coordinating with vendors, sites, and off-site facilities, and ensuring timely submission of regulatory materials.

Responsibilities include overseeing records flow, site audits, TMF checks, and training for investigator sites. Strong MS Office skills and a 2-year clinical research background are required.

Qualifications

• College or university degree or an equivalent combination of education, training and experience.
• Minimum 2 year experience within the clinical research industry, corporate or academic environment.
• Basic proficiency in MS Word, Excel, Outlook, Power Point.
• Knowledge 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 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 updates to the Monitor
• Serves as the main contact point for other departments in administrative site-related issues
• Organizes and prepares reports of internal project team meetings
• Collaborates with sites and project team on Investigator Meetings organization
• On-the-job coaching of Site Management Associates I and Clinical Operations staff
• Arranges and tracks trial training for investigator site teams in vendor-related systems
• Provides training in courier management and trial supplies ordering to sites
• Files trial records in TMF and performs TMF checks
• Participates in TMF and systems audits
• Prepares and updates Investigator Site Files (ISF) and ISF checklists
• Coordinates the translation process for trial records
• Collects IP-REDs and compiles IP-RED packages for review

Skills

MS Word

MS Excel

MS Outlook

MS PowerPoint

Documentation tracking

Education

College degree or equivalent

Tools

MS Office Suite

TMF systems

Job 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.

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

• 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)

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.