Study Start Up Specialist (FSP)
Parexel International Corporation
Position Purpose:The Study Start Up Specialist is an in-house position 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.
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 Seagen processes and timelines.
Assists in resolution of site queries for assigned clinical sites.
Provides regular updates and escalates site issues to Manager, SSU.
May attend weekly start-up meetings with Manager, SSU, Protocol Lead (PL), Clinical Contracts Manager (CCM), Legal, and other key stakeholders as necessary.
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 packets for assigned clinical sites.
Performs second review of essential documents and/or ICFs for other members of the Study Start Up Team.
Mentors junior Study Start Up Team members.
Manages time on assigned clinical sites across one or more clinical studies and escalates issues to Managers, SSU.
Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system/process related training.
Adhere to EP and Client SOPs and processes.
Bachelor of Arts or Science (BA/BS) or equivalent or any relevant and qualifying training.
Minimum of 3 years of relevant clinical trial experience.
Minimum of 3-5 years of pharmaceutical or biotechnology industry, preferred.
Thorough knowledge of clinical start-up process and requirements required.
Knowledge of CFR and ICH/GCP requirements is required.
Requires effective organizational and time management skills.
Able to multi-task under limited direction and on own initiative.
Strong communication and inter-personal skills.
Highly responsive and proactive, a team player.
Previous start-up unit experience, preferred.
Oncology clinical research experience, preferred.
Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint.
Proficiency in written and spoken English
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