Country Study Start-Up Specialist I/ II

CTI; Madrid; Hybrid; EUR 30,000 - 48,000; Full time

Benefits offered by this job

Hybrid work opportunities

CTI Cares program

Job summary

CTI is seeking a Regulatory Affairs Support specialist to assist in Study Start-Up activities for Clinical Trials and Real-World Evidence projects. You will interact with Ethics Committees, Competent Authorities, and the CTI Legal team to ensure compliant submissions and timely approvals.

You will coordinate site budgets and contract translations, maintain internal systems, and support cross-functional project teams in a fast-paced, global environment with hybrid work options.

Qualifications

• 1-2 years of experience in Clinical Research (pharmaceutical, site or CRO service) and experience in regulatory in country.
• Associate's or Bachelor's Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience.
• Fluent in spoken and written Italian and English.

Responsibilities

• Inform the RASSU department about changes in drug law/guidelines and updated submission requirements.
• Review/prepare local submission documents and perform submissions to Ethics Committees and to the Competent Authority for Clinical Trials/RWE.
• Identify ethics committees and authorities for the country and manage related payments.
• Serve as applicant for trials and act as main contact for EC/CA and the assigned RASSU Specialist.
• Communicate with RASSU specialist on EC/CA outcomes and manage study documentation in TMF systems.
• QC/QA of regulatory documents and reports; reconciliation, close-out and archiving.
• Oversee translation of regulatory documents when needed and participate in study meetings.

Skills

Clinical Research

Regulatory knowledge

Fluent Italian

Fluent English

Education

Associate's or Bachelor's Degree in allied health

Job description

WhatYou'llDo:

Support of Regulatory Affairs Study Start-Up (RASSU) department:

• Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level
• Review/prepare local submission documents and performs submissions (Initial submissions, Substantial Amendments and Notifications etc.) to Ethics Committees (Central and Local) and to Competent Authority for Clinical Trials/RWE in accordance with local country requirements (e.g. via portal upload or mail or Email); and deliver final submission package to RASSU Specialist assigned to the study
• Identify the Central and Local Ethics Committees and Competent Authority needed for the study on the country level; process pre-payments to Ethics Committees and Competent Authority; adapts study-related documents (e.g. Informed Consent Forms) to meet each local country’s specifications in cooperation with the RASSU Specialist assigned to the study
• Serve as applicant for Clinical trials/RWE and may act as main point-of-contact for the Ethics Committees and Competent Authority and the assigned RASSU Specialist to the study on the country level
• Communicate closely with RASSU specialist assigned to the study regarding EC /CA outcomes
• Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper
• QC and QA of various study related Regulatory documents and reports
• Perform review, reconciliation, close-out, and archiving activities of study or project
• Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
• Attends internal and external study meetings and regulatory status reports for each site and country during study meetings

Support the CTI Legal team:

• Foster relationships with key contacts at each site
• Facilitate contract-related communication between the site and CTI
• Assist with site contract translation; track the progress by updating and maintaining internal systems, databases and tracking tools (including the Trial Interactive database) with project specific information
• Identify any unique investigator, country or site-specific issues and identifying any ancillary agreements that may be necessary
• Assist with site contract execution

Support Site Budget activities:

• Identify and establish relationship with site personnel responsible for budget proposals
• Interact with project management team members and clinical trials budget manager
• Has exact knowledge about site specific budget templates and experiences of completing such templates
• Train sites to understand budget templates and contents
• Understand and communicate changes made by the site to clinical trials budget managers and vice versa
• Assisting with translation, tracking the progress by updating the Trial Interactive database, sharing drafts and final versions with CTI personnel and delivering the final negotiated budget to site personnel

WhatYou'llBring:

• 1-2 years of experience in Clinical Research (pharmaceutical, site or CRO service) and experience in regulatory in country.
• Associate's or Bachelor's Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
• Fluent in spoken and written Italian and English

AboutCTI

• AdvanceYourCareer-Weinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals.
• JoinanAward-WinningTeam-Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.Wesupportyourwork-lifebalancewithhybridworkopportunities.ThroughourCTICaresprogram,you'llhaveopportunitiestogivebacktoyourcommunityandtheworld.
• MakeaLastingImpact-AtCTI,yourworkdirectlycontributestoadvancingmedicine.You'llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.Together,wemovemedicineforward,makingadifferenceforthosewhoneeditmost.