REGULATORY & STUDY START-UP ANALYST I II III LATAM - Location: São Paulo - SP - Brazil
Hybrid (3x at Vila Olimpia´s office)
Who We Are
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 (Mo H) 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 Mo H, 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:
▪ Independently 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.
Might manage LATAM countries regulatory and logistic deliverables and activities during start-up and maintenance with close communication with 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 Mo H 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 Mo H according to local regulations (e.g.: DSUR, SUSARs, SAEs, Line-listings), if applicable;
Support 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:
▪ University degree in any career related to Health area (Pharmacist, Nursery, etc);
REGULATORY & STUDY START-UP ANALYST I = Minimum of 2 years of experience working in Regulatory or other areas in pharmaceutical companies, clinical sites or CROs;
REGULATORY & STUDY START-UP ANALYST II = Minimum of 3 years of experience working in Regulatory or other areas in pharmaceutical companies, clinical sites or CROs; ▪ REGULATORY & STUDY START-UP ANALYST III = Minimum of 4/ 5 years of experience working in Regulatory or other areas in pharmaceutical companies, clinical sites or CROs;
▪ Advanced knowledge of clinical trials local regulations;
▪ Advanced 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.