Startup Specialist
3 semanas atrás
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Job OverviewPrimary contact with investigative site(s) during site start-up activities and maintenance, responsible for collecting the required investigator and essential documents for a study. Ensure that EC/IRB/Third body/Regulatory Authority and other local applications are made within the timelines and meet regulatory and sponsor specifications. Interact proactively with authorities to provide guidance and stay updated on current standards. Serve as a local expert in project start-up activities and mentor less experienced colleagues.
Summary Of Responsibilities- Maintain awareness of regulatory legislation and guidance in assigned countries.
- Coordinate, collect, and organize data for submissions to authorities.
- Prepare and review study documentation and submissions.
- Liaise with vendors regarding regulatory submissions.
- Ensure start-up and maintenance activities comply with laws, guidelines, and standards.
- Escalate issues timely and perform other duties as assigned.
- In-country tasks include managing site documents, ensuring quality and compliance, supporting site activation, and assisting with negotiations and CTIS tasks as applicable.
- University/College degree in life sciences or related field, with experience in clinical research and knowledge of ICH guidelines and regulations.
- Experience with regulatory submissions, preferably with Anvisa and CEP/CONEP.
- Fluent in English.
- Availability for in-person meetings in Sao Paulo, Brazil.
- At least 2 years in clinical development or regulatory start-up.
- Knowledge of ICH, RA, IRB/IEC regulations, and experience with investigator start-up documents and negotiations.
- Ability to understand and communicate research protocol requirements.
- General Office Environment.
Learn more about our EEO & Accommodations request here.
Additional Details- Seniority level: Entry level
- Employment type: Full-time
- Job function: Legal
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