Study Start Up Specialist II

Key Accountabilities:

SSU Coordination and Execution

• Coordinates, guides, and assists with all start up activities prior to site activation, including but not limited to: Site Informed Consent Form (“ICF”) localization and guidance in line with regulatory/health authority requirements. Ethics Committee (“EC”) information, meeting dates & costs. Ethics applications & associated online systems. Ethics & Governance submission processes. Clinical Trial Health Authority application and regulatory submission process. Contracts & Indemnity request process. For global studies, localize global ICF with country requirements. Local sample application and permit submission processes  

• Maintains up to date knowledge, ensuring adherence and compliance with local regulatory requirements and associated documentation  

• Reviews, analyzes, and collates metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation  

• Ensures all start up information & requirements are kept up to date in a central repository for both global and local study teams  

• Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department  

• Tracks metrics and SSU timelines to identify trends and opportunities for improvement  

Relationship management

• Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial processes, government policies/laws, via innovative approaches  

• Maintains current, and awareness of changes in, startup processes across government, hospital & industry & liaises with stakeholders to resolve any SSU issues  

• Proactively responds to information survey requests by government/ industry bodies  

• Provides continuous and proactive communication with ECs/hospital administration/industry bodies to obtain accurate and up to date information on clinical trial status and activities  

• Maintains communication with local legal/regulatory/clinical operation to ensure input is sought and all internal/external requirements are met  

• Provides guidance to Country Study Managers (CSMs) and Country Study Specialist (CSS) on regulatory/ethics, tracks & drives site activations by regular review and monitoring status of submissions/ activations  

• Collaborates with vendor management and procurement to provide input as required into vendor identification, selection, and Request for Information (RFI)/ Request for Proposal (RFP) process  

• Liaises and shares best practices with other SSU within the region/organization  

New Site Identification

• Assists with identification and tracking of new sites in collaboration with CSMs  

• Performs/coordinates site level feasibility activities including evaluation of patient population and final site selection  

Contracts/ Budget

• Negotiates contracts and study budgets with sites during the SSU phase to ensure finalization  

• Provides local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country  

• Collaborates with CSMs to maintain data to ensure FMV  

• Liaises with management/CSMs to implement budget cost containment and implement contingencies as required  

Compliance with Parexel standards

• Complies with required training curriculum   

• Completes timesheets accurately as required   

• Submits expense reports as required   

• Updates CV as required   

• Maintains a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements  

Skills:

• Demonstrated competence in analysis, planning and problem solving.  

• Excellent communications including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.  

• Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.  

• Ability to make effective decisions.  

• Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility.  

• Demonstrated teamwork and ability to make an active contribution to team performance.  

• Demonstrated computer literacy, to usage of MS Office software, web-based systems, and databases.   

• A flexible attitude with respect to work assignments and new learning.   

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.  

• Willingness to work in a matrix environment and to value the importance of teamwork.  

Knowledge and Experience:   

• >1.5 years of proved SSU experience in clinical trials, experience in global company is preferred.   

• Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in China.   

• Achieved a satisfactory level of technical, functional, and/or professional skill/knowledge in position – related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.  

Education:

• University Degree or equivalent preferably in a medical/science-related field.