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.
Job DescriptionStart 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.
Skills Required
- College or university degree, or equivalent combination of education, training, and experience
- Minimum 2 years of experience within the clinical research industry, corporate environment, or academic environment with administrative and technical experience
- Basic proficiency in Microsoft Word
- Basic proficiency in Microsoft Excel
- Basic proficiency in Microsoft Outlook
- Basic proficiency in Microsoft PowerPoint
- Knowledge of applicable software and project-specific systems following proper training
- Basic English typing skills of at least 40 words per minute
What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com
