REG & STUDY START-UP ANALYST I Colombia OR Argentina Remote

Intrials Clinical Research; Bogotá; Remote; COP 101.849.000 - 165.505.000; Vollzeit

Zusammenfassung

Intrials Clinical Research is seeking a Regulatory & Start-up Analyst I to oversee regulatory submissions, start-up tasks, and import/export documentation for trials in Colombia or Argentina with remote work options.

You will collaborate with regulatory bodies, sponsors, and sites to ensure timely approvals, maintain TMF quality, and support study milestones while adhering to ICH-GCP and local regs.

Qualifikationen

• Bachelor's degree or higher in a health-related field.
• Minimum 2 years in regulatory or related roles in pharma/ CRO.
• Strong knowledge of local clinical trial regulations.
• Solid planning skills for time/scope/quality/budget under supervision.
• Proficient in MS Office and Acrobat.
• Excellent written and spoken English.

Aufgaben

• Lead regulatory and start-up activities for trials, coordinating with PM, sites and sponsors.
• Prepare and review ethics/regulatory/import/export submissions.
• Track progress and ensure timely approvals and document execution.
• Manage regulatory and logistic deliverables with vendors and teams.
• Provide SOP training and participate in local/international meetings.

Kenntnisse

Regulatory knowledge

Project coordination

English proficiency

Communication skills

Attention to detail

Ausbildung

University degree in health-related field

Tools

MS Office

Adobe Acrobat

Jobbeschreibung

Intrials is a disruptive company with all the attributes that a CRO must master. We mix innovative projects with the necessary skills to provide a full service. Nothing stops us in the search for knowledge. Transforming people's lives through science when it comes to solving the challenges of our clients' projects in a focused and exclusive fashion.

Diversity & Inclusion are essential to continue building our history of innovation. Diversity of color, belief, sexual orientation, religion, or any other characteristic are very welcome in all open positions at our company. It is a fundamental part of Intrials to constantly think and implement actions that reinforce the importance of good coexistence with all the people who are part of our DNA and together, to leverage and build true impactful results in our society.

Basic Functions and Responsibilities includes, but are not limited to:

Responsible for the activities related with:

• Regulatory Affairs for Clinical Trials: Local Ethics Committees (LEC)s, Central Ethics Committees (CEC)s, Minister of Health (MoH) and any Additional Review Bodies (ARB)s;
• Study supplies (Investigational Product (IP) and Clinical Trials Material): Importation, Storage, Shipment, Return and Destruction;
• Safety Reports Submission to MoH, if applicable;
• Compliance with applicable SOPs, Work Instructions, local and international regulations, and Good Clinical Practices (ICH-GCP);
• Represent the company as a legal representative before the regulatory bodies, if required;
• Work closely with Project Manager (PM) to define regulatory / importation strategies for the assigned studies, as well as, to review, track and follow up the progress, the approval and execution of documents, including ethics, regulatory and essential documents for the regulatory / logistic area, ensuring successful site activation and delivery study milestones.

Primary Activities includes, but are not limited to:

• Manage country, study and site level regulatory and logistics deliverables during start-up and maintenance with close communication with the internal team, sponsor, sites and vendors.
• Close contact with sites, sponsors, brokers, and regulatory agencies to obtain documentation required for ethics, regulatory and logistic activities for the assigned studies;
• Prepare, review and perform submission of study dossiers (ethics/regulatory/import/export) to ethics and regulatory bodies;
• Track and follow up with sites and regulatory agencies the progress, the approval and the execution of documents for ethics, regulatory and logistics activities;
• Communicate, review and prepare, with close collaboration of sites, internal team and Sponsor, the answers to queries issued by the ethics and regulatory bodies;
• Periodic reports to MoH submission and follow up, if applicable;
• Study supplies management assistance, with close contact with vendors and internal team, ensuring the quality of storage, sites shipment, return and destruction;
• Ensure filling and compliance of regulatory and logistic sections of study TMF;
• Safety Reports Submission to MoH according to local regulations (e.g.: DSUR, SUSARs, SAEs, Line-listings), if applicable;
• Assist the Regulatory & Start-up Manager (RSM), the Regulatory & Start-up Lead (RSL) and/or other team members in the activities under their responsibilities, in accordance to ICH-GCP, local and international regulatory requirements and SOP standards, if required;
• Assist in the revision of the SOPs related to the department activities;
• Provide local regulation trainings to Intrials staff with the RSM and/or RSL support;
• Participate in local or international meetings / courses, aiming to improve knowledge.
• Work in compliance with applicable SOPs, Work Instructions, local and international regulations, and Good Clinical Practices (ICH-GCP)

Requirements for REGULATORY & STUDY START-UP ANALYST I

Colombia OR Argentina Remote:

• University degree in any career related to Health area (Pharmacist, Nursery, etc);
• Minimum of 2 years of experience working in Regulatory or other areas in pharmaceutical companies, clinical sites or CROs;
• Advanced knowledge of clinical trials local regulations;
• Intermediate planning skills for time, scope, quality, budget management for studies under RSM/RSL supervision;
• Deep knowledge of Office software and Adobe Acrobat software;
• Advanced knowledge of oral and written in English;
• Individual must be dynamic, adaptable and with good communication skills;
• Organized, strong attention to detail, documentation, and follow-up.