The Study Start-Up Country Specialist works in collaboration with project teams and in collaboration with the Study Start-up Manager to perform key study start-up tasks in their country, or countries, of expertise. This tasks include study feasibility, site identification and qualification up to and including pre-study visits, facilitation of site contract and budget negotiations, review of document translations and regulatory and ethics committee submissions, and other study start up activities, as assigned by the Study Start-Up Manager or designee. The Study Start-Up Country Specialist is responsible for facilitating the collection of essential regulatory documents from sites and preparation or review 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.
Job Duties and Responsibilities:
Provides country-level expertise and support to study start-up team and project team
Assists the Legal team with the completion and distribution of Confidential Disclosure Agreements (CDAs)/Clinical Trial Agreements (CTAs), as well as providing intermediation, as necessary, to support the execution of agreements with sites within their country of expertise.
Identifies and builds relationships with sites and investigators within country of expertise
Participates in the identification and selection of sites and investigators, including national lead investigators, as necessary
Coordinates the distribution and collection of Feasibility Questionnaires (FQs) to sites in assigned countries and follows up accordingly to ascertain interest and to meet study timelines.
Assists with distribution and review of site essential documents either directly or through coordination with assigned CRAs in specific countries
Assists with the creation, translation (native speaker or sufficiently skilled in the local language(s) to translate / review translations), and review of regulatory documents specific to local and central Ethics Committee (EC) submission requirements
Translate, review, draft local language documents, as necessary to support the interaction with local authorities.
Assists with the creation, translation, and review of regulatory documents for Competent Authority (CA) clinical trial applications (CTA, or equivalent) and submissions or notifications to other regulatory agencies, as applicable.
Responsible for the collection and maintenance of the current Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for the assigned countries
May draft cover letters, correct ICFs, review translations, provide summarized translations for GNA/deficiencies, and communicate with the CEC and/or CA in local language, as necessary.
Ensures completeness and accuracy of Feasibility Questionnaires, CDAs, CVs and essential regulatory document from sites from study start-up phase until site initiation
Perform timely and accurate data entry of Study Start Up (“SSU”) status and documents, regulatory documents and submission status of country/site information in TEMPO
May be responsible for translation of requested SSU documents and communication link with translation vendor
Other duties as assigned by the SSU Manager, Country Manager, Director of Regulatory Affairs, or designee per project-specific requirements
Bachelor’s graduate with a healthcare or life science degree or equivalent experience
Minimum of 2 years of experience in on-site monitoring of clinical studies and regulatory affairs preferably in the CRO industry
Strong written and verbal communication skills
Native-level or equivalent fluency with local language sufficient to translate / review / draft local language documents
Strong interpersonal skills
Comprehensive knowledge of GCP/ICH guidelines
Proficiency in medical terminology
Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
Attention to detail
Ability to work in a matrix environment
Strong time management and organizational skills
Fluent in English and local country language
Has proven experience in SSU activities and in preparation of regulatory submission package to CA/ EC in accordance to GCP, ICH guidelines and to country specific standards.
Adheres to study timelines, documents study challenges, document collection and communicates updates to SSU PM and/or SSU Manager.
Demonstrates strong written and verbal communication skills.
Proficient computer skills, including Microsoft Office