PSI is a leading Contract Research Organization with more than 22 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Hybrid remote/office working arrangement in Milan area.
Job Description
The scope of responsibilities will include:
Start-up Responsibilities:
- Involvement with in-house and on-site activities related to site identification and new clinical trial placement.
- Setting clinical trials related collaboration with medical professionals.
- Ensuring comprehensive internal handovers from Feasibility to Operations.
- Defining the optimal site profile for a study and recommending the best, high-quality sites after contacting and evaluating their capabilities and potential for study conduct.
- Reviewing therapeutic indication and study-specific materials prior to contacting sites.
- Creating and/or maintaining a site identification tracker.
- Regularly communicating with Project Teams to update them on the status/progress of the site ID, as well as highlighting any potential risks or issues to timelines or objectives.
Ongoing Project Responsibilities (all phases):
- Creating and maintaining a therapeutic area-specific site database.
- Assisting Project Teams during the enrollment phase by identifying additional sites when necessary.
- Developing strategies to accelerate site identification through the use of external databases like Citeline and CenterWatch, contacting SMOs, site networks, advocacy and support groups, and central IRBs.
- Training CTAs and CRAs on how to get the best information from sites, acting as a trainer and mentor.
- Participating in the preparation of presentations for client and bid defense meetings, providing input in various regulatory aspects (as requested).
Qualifications
- Life sciences degree (proven CRA experience is a plus).
- Experience of working in practical healthcare settings (hospital, outpatient clinic) is a strong plus.
- Prior experience in Site Identification/Study Start-Up activities is a strong plus.
- Practical experience in clinical trials related activities (study coordinator, sub-investigator) is a strong plus.
- Excellent written and oral communication skills, as well as time management skills.
- Demonstrates the ability to multitask under compressed deadlines across several projects, each with unique requirements.
- Advanced English and native Italian.
You are dynamic, curious, passionate, driven, and dedicated. If you can’t stand mediocrity and embody excellence in all you do, you might be the team member we're looking for.
Additional Information
Our team is searching for a clinical trials savvy candidate who is a relationship pro, dedicated to connecting with medical institutions to advance clinical trials in the best way.
If you feel it is time to make your skills and knowledge visible within a growing company with a true focus on its people, then PSI is the right choice for you. You will be on the frontline of new medications development and will work closely with cross-functional experts to drive your startup projects forward.