What are the responsibilities and job description for the Study Start Up Specialist position at ProPharma Group?
The Study Start-Up Specialist position is responsible for overseeing and leading study start-up activities in collaboration with other clinical research stakeholders.
Essential Functions :
Update knowledge on related regulatory requirements, ensuring adherence and compliance with local regulations and internal procedures.
Execute all start-up activities prior to site activation on assigned studies, according to standards and aligned with study / project requirements and timelines.
Prepare country level Informed Consent Form (ICF) and obtain ethics committee and local regulatory approval.
Prepare ongoing submissions, amendments, and periodic notifications required by ethics committees and regulatory authorities.
Maintain and analyze study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
Partner with other study team members to provide guidance on regulatory and ethical requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions / activations.
Support 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, identify and track new investigator sites performing feasibility, as applicable, and develop and support effective patient recruitment and retention practices, as required.
Responsible for study budget and contracts negotiation in collaboration with contracts manager / associate, as required and ensure compliance with Fair Market Value (FMV) in the region.
Other duties as assigned.
Necessary Skills and Abilities :
Basic knowledge of clinical start-up processes and requirements required.
Able to prioritize and manage a large volume of work and show attention to detail.
Excellent communication and interpersonal skills with the ability to interact with many people of varying levels of responsibility for clinical trial programs.
Able to write clearly and summarize information effectively.
Able to build and maintain positive relationships with management and peers.
Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, PowerPoint) applications to prepare charts, tables, forms, reports, and presentations.
Educational Requirements :
Bachelor's degree or equivalent curriculum (scientific or healthcare discipline preferred).
Experience Requirements :
- 5 years' experience in clinical research, 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
- 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.
- Experience with e-mail and calendar programs.
- Experience with IVRS and EDC systems a must.
