Study Start Up Specialist - FSP

ABOUT THIS ROLE

Job Purpose:

The Study Start-up Specialist (SSU Specialist) is responsible for supporting site start-up activities, including collection and review of essential documents, and reviewing and approving Informed Consent Forms (ICFs) for ethics committee submissions for assigned clinical sites.

Supporting Activities:

• Accountable for site start-up for assigned clinical sites
• Serves as site’s primary point of contact for start-up, resolving site queries and assisting sites with ethics committee submissions
• Sends start-up packets
• Reviews and approves ICFs pre- and post-ethics committee submission
• Collects, reviews, approves, and tracks essential documents, and reviews and approves ICFs in accordance with Client processes and timelines
• Assist in resolution of site queries for assigned clinical sites
• Provides regular updates and escalates site issues to Manager, Study Start-up (SSU)
• Forecasts and tracks metrics and progress of site start-up for assigned clinical sites ensuring all sites are greenlit on time per Study Start-up timelines
• Ensures metrics in clinical trial management systems are up to date and accurate
• Ensures site essential documents are uploaded to electronic Trial Master File (eTMF) accurately and on time for site greenlight
• Prepares greenlight packages for assigned clinical sites
• Manages time on assigned clinical sites across one or more clinical studies and escalates issues to Managers, SSU
• May prepare and perform Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) amendment activities, as required
• Contribute to Clinical Contract and Study Start-up quality, systems, and process initiatives
• Support study Start-up managers with diverse tasks as appropriate and as required
• May attend weekly start-up meetings with Manager, SSU, Protocol Lead (PL), Clinical Contracts Manager (CCM), Legal, and other key stakeholders as necessary
• Performs second review of essential documents and/or ICFs for other members of the SSU team
• Mentors junior SSU team members
• 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 complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• Requires effective organizational and time management skills
• Able to multi-task under limited direction and on own initiative
• Strong communication and interpersonal skills
• Highly responsive and proactive
• A team player
• Proficient with Microsoft Office Products - Word, Excel, PowerPoint, SharePoint
• Proficiency in written and spoken English required
• Proficiency in local language as applicable

Knowledge and Experience:

• Minimum of four (4) years of relevant clinical trial experience working in Pharma, Biotech or Clinical Research Organization (CRO) environment
• Minimum of two (2) years of clinical trial Start-up unit experience
• Thorough knowledge of clinical start-up process and requirements required
• Oncology clinical research experience preferred
• Bachelor of Arts or Science (BA/BS) or equivalent or any relevant and qualifying training

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.