Project Support Specialist II
J
JobgetherClinical research
Based in BrazilFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Professional fluency in English
- Experience
- At least 2 years of relevant professional experience or demonstrated competencies in project support, clinical research coordination, or related operational functions.
- Required Skills
- Microsoft ExcelMicrosoft OfficePowerPoint
Requirements
- Bachelor's degree or international equivalent, preferably in business, science, healthcare, or a related discipline; equivalent professional experience may also be considered.
- At least 2 years of relevant professional experience or demonstrated competencies in project support, clinical research coordination, or related operational functions.
- Professional fluency in English, with strong written and verbal communication skills.
- Advanced working knowledge of Microsoft Office, particularly Outlook, Word, Excel, and PowerPoint.
- Working knowledge of ICH-GCP, standard operating procedures (SOPs), and applicable regulatory guidance.
- Strong organisational and administrative skills to coordinate multiple priorities, maintain accurate documentation, and meet deadlines.
- Attention to detail and ability to identify inconsistencies, follow procedures, and maintain high-quality project records.
- Ability to collaborate across cross-functional teams and work independently, exercise sound judgment, and escalate issues when needed.
Responsibilities
- Coordinate internal and external project meetings, including scheduling, agendas, minutes, feedback, and Trial Master File documentation.
- Maintain project timelines using MS Project or similar tools, collect progress updates, and communicate changes to stakeholders.
- Coordinate study training, track completion, maintain records, and escalate compliance gaps.
- Establish study collaboration spaces and manage user access to clinical study systems.
- Coordinate study supplies, liaise with vendors, and verify cost estimates, invoices, and payments.
- Maintain project trackers, financial records, team assignments, and time-reporting processes.
- Support distribution and tracking of clinical safety documentation, including IND Safety Reports, SUSARs, and CIOMS.
- Coordinate translation of site-level documentation and preparation, distribution, and reconciliation of study materials.
- Support project plans, reports, KPIs, inspection readiness reviews, dashboards, and study progress updates.
- Track out-of-scope activities and prepare supporting documentation for change order submissions.
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