Site Start-Up Associate II / Sr. Site Start-Up Associate
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
We’re looking for a talented and energetic Site Start-Up Associate to join our team!
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
As the Site Start-Up Associate, you’ll have the opportunity to perform all country specific tasks associated with the start-up of a clinical trial in accordance with regulations, standards, and study-specific requirements.
What you’ll be doing:
- Quality deliverables at the country level for site start-up in one or more components.
- Proactively forecast submission/approval timelines and ensures they are adhered to. If forecasted timelines are not reached, provide clear rationale for delays and contingency plans
- Serve as primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects.
- Prepare and submit Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submission, as well as ongoing submissions, amendments, and periodic notifications required by central and local EC and RA; provide regular updates of country specific information on the clinical trial application database on SharePoint; submit end of study notifications to Regulatory Authorities, Ethics Committees/Review Boards and other local authorities
- Perform essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance regulatory requirements and ICH/GCP guidelines.
- Produce site-specific contracts from country template and submit proposed contract and budget negotiate budget and contract with site and via Contracts Lead with Sponsor
- Ensure accuracy and completeness of trial master file documents submitted during start-up and perform QC review of files before transfer to Maintenance for filing in TMF.
- Provide all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up.
- Collect information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies
- Liaise with internal team members to review areas that impact study start-up and shares start-up information with the project team.
- Provide country-level intelligence on site start-up and ensures that local country regulatory intelligence is maintained on the central repository, e.g.
- Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/ export license applications where these are obtained with RA applications.
- Ensure documentation of QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client.
You’ll need this to be considered:
- Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
- 1 – 2 years of related experience (health sciences, biology degree) including clinical trials support and experience in the submission of clinical trial applications.
- Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge regulatory requirements Proficient in the development and review of Informed Consent Form templates for conducting clinical trials
- Proven experience working with internal and external customers/vendors to meet project specific goals; is customer-service focused in approach to work; Strong verbal and written communication and negotiation skills
- Excellent team player, maintaining a positive, results orientated work environment
- Ability to multitask and work effectively in a fast-paced environment with changing priorities and working with multiple clients; excellent organizational and time-management skills, able to prioritize work to meet deadlines
- Accountable, dependable and strong commitment