Site Management Associate II

Psi CRO; Pennsylvania; On-site; USD 60,000 - 80,000; Full time

Job summary

PSI CRO is seeking an organized Site Operations Administrative professional to join our clinical operations team. You will support site management, manage TMF records, coordinate regulatory submissions, and handle site communication and training.

In this role, you will liaise with sites and internal departments to ensure smooth trial administration, document control, and audit readiness while maintaining strict regulatory standards across multiple countries.

Qualifications

• College degree or equivalent combination of education, training and experience.
• Minimum 2 years experience in the clinical research industry in an administrative role.
• Basic proficiency with MS Word, Excel, Outlook and PowerPoint.

Responsibilities

• Main site contact for non-trial-participant and non-protocol issues including vendors and access management.
• Manages records flow with sites and off-site facilities.
• Prepares regulatory and ethics submission/notification documents and records.
• Coordinates payments to sites and off-site facilities.
• Prepares for site audits and inspections and follows up on findings.
• Reviews and coordinates site-specific query resolution with monitors and sites.
• Tracks TMF and conducts TMF checks at site and country levels.
• Organizes internal project team meetings and prepares reports.

Skills

MS Word basics

MS Excel basics

MS Outlook basics

MS PowerPoint basics

English typing 40 wpm

Education

College/University degree or equivalent

Tools

MS Word

MS Excel

MS Outlook

MS PowerPoint

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.