PSI is a leading Contract Research Organization with 30 years experience 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.
Job DescriptionTake your career to the next level and be involved in study startup processes in the UK. You will provide direct operational support to project teams, ensure that clinical projects start smoothly and on time and support PSI in developing the local study startup team.
This role is hybrid with 2 days based in our Oxford office.
- Perform study startup activities and support all processes critical for site activation.
- Collect site documents for IRB/IEC submission and/or IP-RED process.
- File study-specific documentation in TMF, in accordance with Document management plan.
- Compile IP-REDs packages assuring high quality.
- Review study-specific translations, including patient-facing documents.
- Facilitates site agreement and/or budget negotiations with sites to ensure alignment to the site activation plan.
- Ensure initial distribution of locally obtained clinical study supplies to sites and supervise initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites.
- Identify project-specific issues and escalates to Regional (Startup) Lead/PM and operational Manager in the country.
- Develop site-specific startup timelines and is responsible for meeting the site activation targets under supervision.
- College/University degree or an equivalent combination of education, training and experience
- At least 4 years' experience in clinical research
- At least 3 years of full-scope Study Startup experience
- Excellent knowledge of ICH GCP, local laws and applicable regulations in the region
- Full working proficiency in English
- Communication and organisational skills
- Ability to negotiate and build relationships at all levels
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.
Skills Required
- College or University degree or equivalent combination of education, training and experience
- At least 4 years' experience in clinical research
- At least 3 years of full-scope Study Startup experience
- Excellent knowledge of ICH GCP, local laws and applicable regulations
- Full working proficiency in English
- Strong communication and organisational skills
- Ability to negotiate and build relationships at all levels
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
