Premier Research · 11 hours ago

Site Start up Associate II

United States

Full-time

Remote

Mid, Senior Level

$74K/yr - $74K/yr

5+ years exp

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BiopharmaBiotechnology

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Responsibilities

Takes responsibility for quality deliverables at the country level for study start-up; follows project requirements and applicable country rules.

Forecasts submission/approval timelines and ensures they are adhered to. Provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified. May serve as the primary point of contact for the Project Manager, Clinical Lead, Regulatory Start-up Manager (or designee) during start-up on allocated projects.

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· Ensures documentation of QC of eTMF within the scope of File Management Plan (FMP) 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.

Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.

Qualification

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Clinical trial applicationsRegulatory submissionsStudy Start-UpContract preparationInterventional studiesNon-interventional studiesMedical Device studiesGMO studiesObservational studiesQuality Control (QC)Pharmacovigilance reportingLeadership experience

Required

Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional

Proven experience as a SSUA I and/or 5+ years of related experience, including at least 3 years of experience in the submission of clinical trial applications

Experience working on different study types/phases such as interventional IMP studies, non-interventional studies, Medical Device studies, GMO studies, and observational studies

Experience leading larger programs through start-up

Experience in the contract preparation is essential