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About the Role
Start your career in clinical research, streamlining communication, maintaining systems and managing documents.
Responsibilities
- Serve as the main site contact for non-trial-participant and non-protocol related issues, including vendors, trial supplies, and access management.
- Manage records flow with sites and off-site facilities.
- Prepare regulatory and ethics committee submission/notification documents and records.
- Coordinate payments to sites and off-site facilities.
- Prepare for and follow up on site audits and inspections.
- Review and coordinate site-specific query resolution with Monitors and sites.
- Review site-specific EDC completion progress and provide Monitors with regular updates.
- Act as the main contact point for other company departments on administrative site-related issues.
- Organize, participate in, and prepare reports for internal project team meetings.
- Collaborate with sites and project teams on Investigator Meetings' organization.
- Provide on-the-job coaching of Site Management Associates I and Clinical Operations Administrative Support staff under supervision.
- Arrange and track initial and ongoing trial training for investigator site teams in all vendor-related systems.
- Provide training in courier management and trial supplies ordering to investigator sites.
- File trial records in the TMF and perform regular TMF checks on a site and country level.
- Participate in and follow up on TMF and systems audits.
- Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
- Coordinate the translation process for trial records on a site and country level.
- Collect IP-REDs and compile IP-RED packages for further review.
Requirements
- College or university degree or an equivalent combination of education, training and experience.
- Minimum 2 years of experience within the clinical research industry, corporate or academic environment.
- Basic proficiency in MS Word.
- Basic proficiency in MS Excel.
- Basic proficiency in MS Outlook.
- Basic proficiency in MS Power Point.
- Knowledge of applicable software and project-specific systems (following proper training).
- Basic typing skills in English (minimum 40 words per minute).
Skills
- MS Word
- MS Excel
- MS Outlook
- MS Power Point
- Typing
Experience Level
- Minimum 2 years experience within the clinical research industry, corporate or academic environment
Education Level
- College or university degree or an equivalent combination of education, training and experience
About the Company
- 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 than 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.
Equal Opportunity
- For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.