Job Description The Specialist/Senior Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU RA management plan.
They also serve as a liaison between SSU/regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing SSU and regulatory deliverables following project, corporate and industry regulatory strategies.
DUTIES AND RESPONSIBILITIES: Support the SSU/Regulatory Lead to project site-specific submission/approval timelines and ensure they are met; if forecasted timelines are not reached, provide clear rationale for delays and contingency plans to mitigate impact.
Anticipate and identify site issues during the start-up process and resolve minor to moderate issues independently.
Prepare, collect, review regulatory information and documents to support submissions to FDA, EMA and national authorities (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) as well as Ethic Committees/IRBs for initial authorisation and maintenance, in compliance with the applicable regulations.
Collect, review for completeness and compliance, and track essential documents to facilitate efficient site initiation and activation.
Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information.
Prepare study team reports or updates regarding the status of essential document collection, review and approval.
Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development and regulatory/EC submissions/approvals.
Participate in ICF development, review, negotiation and approval processes.
Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation.
Support feasibility, site identification and site documents customization (i.e.
informed consent document) as needed and closely follow up with investigative sites for updates/resolution.
Arrange for and/or review translation of essential documents as required.
Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific requirements.
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