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Salary
PSI is a leading Contract Research Organization (CRO) with more than 25 years of experience in the pharmaceutical industry.
PSI is a privately-owned, full-service globally operating CRO. PSI’s global reach supports clinical trials across multiple countries and continents and we are known to be highly selective about the work we pursue. We focus on delivering quality and on-time services across a variety of therapeutic indications.
With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its customers, employees, sites, and vendors.
Job Description
As a Senior CRA (Radiopharmaceuticals) you will participate in the preparation and execution of Phase I-IV oncology clinical trials with particular focus on radiopharmaceutical studies including startup and site monitoring activities to ensure timelines and deliverables are met at assigned sites. You will build and maintain strong relationships with clinical sites and investigators and assess protocol and regulatory compliance in accordance with applicable local and federal regulatory requirements, ICH GCP and PSI SOPs. You will focus on subjects’ rights, safety and well-being and ensure a high quality of data.
Responsibilities include:
- Prepare, conduct and report on activities related to the completion of site selection, initiation, routine monitoring and close-out visits
- Monitor patient enrollment to ensure recruitment targets and project timelines are met at the site and/or country level
- Perform source data verification and follow up on data queries at the site level, on-going review of any Risk Based Monitoring related information influencing data quality and frequency of site visits
- Ensure accurate and timely reporting and follow up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations
- Act as the main line of communication between the Sponsor and the site
- Be a point of contact/liaison for in-house support services and vendors
- Ensure proper handling, accountability and reconciliation of all Investigational Product(s) and clinical study supplies
- Review the status and contents of essential documents at the site level and reconcile study OSF/ TMF at site and/or country level
Qualifications
- Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
- Minimum of 3 years’ site monitoring experience.
- Prior experience in Radiopharmaceuticals is required.
- Strong experience in Oncology required.
- Experience with all types of monitoring visits in Phase II and/or III.
- Full working proficiency in English.
- Proficiency in MS Office applications.
- Ability to plan, multitask and work in a dynamic team environment.
- Excellent Communication, collaboration, and problem-solving skills.
- Ability to travel up to 65% (depending on project needs).
- Valid driver’s license (if applicable).
Additional Information
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.
