Premier Research
Biotech, Medtech, Specialty Pharma
Sr/SiteStartUpAssociateII
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“Sr/Site Start Up Associate II at Premier Research. Skills: Clinical trial applications, Regulatory submissions, Site start-up, Contract negotiation. Prepare and submit Central EC/IRB Applications. Submit Local EC Applications”
What You'll Achieve.
Deliver medical innovation; Meet sponsor requirements; Meet investigator requirements; Ensure compliance with local regulatory requirements; Ensure compliance with ICH/GCP guidelines; Resolve contract issues; Execute contracts; Meet expectations for site start-up tasks; Deliver site start-up tasks in accordance with contracted timelines
Industry & Context.
Issue resolution
What They're Looking For.
Must Have
Undergraduate degree or international equivalent in clinical, science, or health related field or licensed healthcare professional, 5+ years related experience, 3+ years experience in clinical trial applications submission, Experience with interventional IMP studies, Experience with non-interventional studies, Experience with Medical Device studies, Experience with GMO studies, Experience with observational studies, Fluent English, Fluent in host country language
Nice to Have
Licensed healthcare professional
What You'll Do.
Prepare and submit Central EC/IRB Applications
Submit Local EC Applications
Submit RA Applications
Submit other local regulatory authority submissions
Submit hospital approval submissions
Assist with EC/IRB or CA issue resolution
Prepare ongoing submissions
Prepare periodic notifications
Submit safety reporting
Submit end of study notifications
Perform essential document collection
Review essential documents
Produce site-specific contracts
Submit proposed contract and budget for review
Negotiate budget and contract with site
Conduct site identification process
Confirm investigator interest and eligibility
Liaise with Site Identification Lead
Assist Medical Informatics team with site outreach
Prepare Investigational Product checklist
Ensure accuracy and completeness of Trial Master File
Perform QC review of files
Provide regulatory documents to Clinical Research Associate
Provide study correspondence to Clinical Research Associate
Provide translations to Clinical Research Associate
Collect information on submission deadlines
Collect timeline metrics for RAs
Liaise with internal team members
Review areas impacting study start-up
Share start-up information with project team
Provide country-level intelligence on site start-up
Maintain local country regulatory intelligence
Provide guidance on data protection compliance
Set up and maintain folder with country ECs/IRBs
Set up and maintain folder with local authority
Set up and maintain folder with local authority
Set up and maintain details of existing site
Set up and maintain details of institution contract
Set up and maintain necessary templates
Set up and maintain fees
Provide quality review of informed consent
Adapt informed consent template
Adapt other patient documents
Adapt specific documentation required in country
Work within scope of Regulatory Start Up plan
Work within study processes
Work within applicable regulations
Provide regular updates of country specific information
Enter trial status information into tracking databases
Maintain trial status information into tracking databases
Ensure documentation of QC of eTMF
Support preparation of specific start-up strategy
Provide training for local employees
Provide training for other applicable internal teams
Review SOPs related to Study Start-Up
Review WGs related to Study Start-Up
Review ADs related to Study Start-Up
Review SOPs related to regulatory tasks
Review WGs related to regulatory tasks
Review ADs related to regulatory tasks
Review SOPs related to country specific pharmacovigilance reporting
Review WGs related to country specific pharmacovigilance reporting
Review ADs related to country specific pharmacovigilance reporting
Serve as primary liaison for site start-up issues
Serve as primary liaison for site start-up management
Escalate issues to RSM
Ensure all site start-up tasks meet expectations
Ensure site start-up tasks are delivered in accordance
Interact with clients
Interact with vendors
Interact with other functional areas
Act as secondary project contact for site issues
Act as secondary project contact for site questions
How You'll Work.
Team & Collaboration
Cross-functional teams; Internal team members; Project team; Global Study Start-Up portal; Site; Clients; Vendors; Other functional areas
Process & Methodology
Regulatory Start Up plan, File Management Plan
Full Job Description
Premier Research is looking for a Sr/Site Start Up Associate II to join our Global SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. * We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. * Your ideas influence the way we work, and your voice matters here. * As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. **What you 'll be doing:** * Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Assists with EC/IRB or CA issue resolution at the country level. * Prepares ongoing submissions, amendments, and periodic notifications (including safety reporting) required by central and local EC and RA, and other local regulatory authorities as needed within the country, as required by local rules. Submits end of study notifications to RA, ECs/IRBs and other local authorities in the specified country according to national timelines. * Performs essential document collection and review, ensuring that sponsor and investigator requirements are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines. * Local Investigator Contract and Budget Negotiator (where applicable) - produces site-specific contracts from country template. Submit proposed contract and budget to the site for review. Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution. * Conducts the site identification process by contacting sit
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