Study Start-Up Country Specialist Ii
vor 3 Wochen
Job Title: Study Start-Up Country Specialist II (ROW)Job Location:
Australia, HomebasedJob Overview:The Study Start-Up Country Specialist (SSUCS II) works in collaboration with project teams and the Study Start-up (SSU) Manager to perform key SSU tasks in their country or countries of expertise.
These tasks may include study feasibility, facilitation of site contracts and budget negotiations, review of document translations, submission to the Regulatory Bodies (Competent Authority and Ethics Committee (IRB/IEC)), and other study start-up activities as assigned.
The SSUCS II is responsible for the collection of essential regulatory documents from sites and preparation of country-related submission packages in accordance with ICH-GCP and all applicable regulations, laws, guidelines, and ethical standards within specific timelines and quality standards.
May coach, mentor, or onboard junior Specialists.Job Duties and Responsibilities:Independently provides country-level expertise and support to SSU team and project team.Assists the Legal team with the completion and distribution of Confidential Disclosure Agreements (CDAs) and provides intermediation as necessary.Builds relationships with sites and investigators within country of expertise.Participates in the identification and selection of sites and investigators, including national lead investigators.May facilitate the distribution and collection of Feasibility Questionnaires (FQs) to sites and follow up accordingly.Responsible for distribution, collection, and review of site essential documents directly or through coordination with assigned CRAs.Creates, translates, and reviews regulatory documents specific to applicable Regulatory Bodies' submission requirements.Assists with the creation, translation, and review of regulatory documents for Clinical Trial Applications (CTA, or equivalent).Responsible for the collection and maintenance of submission information for the applicable Regulatory Bodies.Under supervision, may Quality Check (QC) submission dossiers for Regulatory Bodies.Provides submission strategy based on practical experience.Performs submissions or notifications to the applicable Regulatory Bodies.May draft cover letters, review translations, and communicate with the applicable Regulatory Bodies.Independently responsible for the adaptation of Country and/or Site Informed Consent Form (ICF).Responsible for review and negotiation of site study budget and serve as liaison between Legal department and sites.Perform timely and accurate data entry of SSU status and documents in applicable tracking systems.May be assigned to coach, mentor, or onboard new hires or junior Specialists.Contributes to functional improvement initiatives.Other duties as assigned by the SSU Manager, SSU & Regulatory Lead, Country Manager, or Director of SSU.Supervisory Responsibilities:No supervisory responsibilities.Job Requirements:Education
Bachelor's degree in healthcare or life sciences or equivalent experience.
Experience
Minimum 3 years of experience as SSU Specialist or study Regulatory Specialist preferably in the CRO or pharma industry.
Skills/Competencies
Strong written and verbal communication skills.Native-level or equivalent fluency in local language sufficient to translate/review/draft local language documents.Strong interpersonal skills.Comprehensive knowledge of ICH-GCP guidelines.Proficiency in medical terminology.Able to exercise judgment within defined procedures.Attention to detail.Problem-solving skills.Ability to work in a matrix environment.Strong time management and organizational skills.Fluent in English and local country language.
Capabilities
Demonstrated experience in SSU activities and preparation of Regulatory submission packages.Adheres to study timelines and communicates updates to SSU Manager and/or Project Manager.Proficient in Microsoft Office.
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