Job Description

The Study Start-Up Specialist (SSUS) is responsible for all SSU-related activities in the country/ region, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.

Essential Functions Include:

• Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
• Executes all start-up activities prior to site activation on assigned studies, according to standards and aligned with study/project requirements and timelines.
• Prepares country level Informed Consent Form (ICF) and obtains ethics committees' and local regulatory authorities' approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country.
• Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
• Partners with other study team members to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.
• Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory /Quality department, as required.
• In collaboration with Clinical Site Manager, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
• Responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value (FMV) in the country.
• Other duties as assigned.

Qualifications

Qualified candidates must have:

• Bachelor’s degree or equivalent curriculum (scientific or healthcare discipline preferred). Persons without a formal degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.
• Minimum 5 years of clinical research experience required, specifically in study start up.
• Experience in managing and in meeting agreed targets on clinical deliverables during the start-up phase of a project.
• Multi-country coordination experience or exposure to more than 1 country + cross cultural awareness.
• Basic knowledge of clinical start-up process an requirements required
• Must be able to prioritize and manage a large volume of work and show attention to detail.
• Excellent communication and interpersonal skills are essential as the COS interacts with many people of varying levels of responsibility for clinical trial programs.
• Must be able to write clearly and summarize information effectively
• Must have the ability to build and maintain positive relationships with management and peers.
• Experience using computer applications including spreadsheets, email, word-processing software and web-based systems.
• Experience working as an in-house CRA or regional CRA/monitoring is highly preferred.
• Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, PowerPoint) applications to prepare charts, tables, forms, reports, and presentations.
• Experience with e-mail and calendar programs.
• Experience with IVRS and EDC systems a must.

Additional Information

• All candidates must be legally eligible to work in the United States. 
• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.