Study Start Up Specialist
Fortrea · São Paulo
Summary of Responsibilities:
- Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives
- Generate and provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools
- Proactively identify and escalate issues that arise related to support SSU deliverables
- Effectively execute against assigned activities within SSU
- Support implementation of standards for global SSU team
- This may include:
- Oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements
- Implementation of the SSU Strategy for assigned region during the study start up period
- Building relationships with internal counterparts and site staff to support successful site activation strategies
- Projecting site activation timelines and appropriately escalating when things get off track
- Adhering to process and tools designed to the support of the SSU team with day-to-day activities
- Leading the preparation of study level essential document templates
- Aiding in the preparation of content for Regulatory submissions
- Handling ICF negotiations and facilitating any required escalations
- Preparation and submission of IMP Release Packages
- Maintaining accurate and timely information in relevant clinical systems
- Responsible for complying with regulations and guidelines and ensuring adherence in support of assigned clinical trials. This position has no direct reports but may provide guidance/oversight to contract staff.
Qualifications (Minimum Required):
- BS/BA degree or Associates degree with ≥2 years of experience in the health care field or direct clinical trial related experience.
- Must have knowledge of clinical trial conduct
- General knowledge of drug development and ICH/GCP guidelines
- Requires proven project management skills
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- Advanced / Fluent in English.
- Minimal (0-5%) travel required
Please, submit your English resume
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