Abbott Clinical Studies Start Up Specialist in Solihull, United Kingdom
The Clinical Studies team are looking for a UK-based Clinical Studies Start Up Specialist , to support regulatory activities at the study start up stage, focused on the preparation of documents for submission to ethics committees (EC) and competent Authorities (CA), especially country and site-specific Patient Informed consent adaptation, obtaining documents required for submission, and supporting the process until approval is granted. Handling of amendments and periodic reporting to EC and CA during the course of the study is another key responsibility of this role.
• Prepare documents for Ethics Committee/Competent Authority (EC/CA) submission
• Initiate translation of documents as applicable; review and adapt translations to appropriate verbiage.
• Prepare Country/Site Specific Patient Informed Consent form according to Regulatory and EC requirements and obtain internal approval where applicable.
• Interpret clinical study protocols in order to support EC/CA submission where layman terms are required
• Point of contact of EC /CA
• Support approval process (adaption of documents according to EC/CA requirements; responses ….)
• Support budget adoption to country and site requirements.
• Prepare submission to any other authority when applicable
• Maintain local regulatory documents on paper or electronically as applicable and ensure upload to data management system (DMS) were applicable.
• Provide support to CPL / Clinical Project Teams
• Assists in the development and review of informed consent document/patient information sheet to ensure all required elements are included.
• Assist with collection of site activation documents.
The ideal candidate will be located a commutable distance from either the Solihull or Maidenhead sites. Candidates should have a secondary/high school qualification, alongside either a Bachelor’s degree or relevant experience within clinical research in pharma/medical devices or clinical experience in a hospital setting. Good IT skills, including working with databases, are required. A familiarity with cardiac, vascular and/or neuromodulation technologies would be ideal, alongside experience with clinical research processes, IRAS, MHRA submissions etc. Candidates must be able to work well independently within minimal supervision, but also demonstrate an ability work collaboratively, in a highly-matrixed business. Strong verbal and written communication skills, interpersonal and organizational skills are also required, with excellent attention to detail.
As you’d expect from a global healthcare company, we offer a fantastic range of benefits including competitive salaries, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com