FSP Study Start-Up Associate

Job Overview

Primary contact with investigative sites during study maintenance and -when assigned-, site startup activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team.

Summary Of Responsibilities

• Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.
• Aid senior staff in compiling, preparing, submitting, and obtaining approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements.
• Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
• Perform a review of final submission documents as applicable.
• Organize communication related to the submissions/outcomes within Fortrea as applicable.
• Escalate study issues appropriately and in a timely fashion.
• Perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable).

In Country Specific Tasks (Global)

• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
• Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance.
• Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines.
• Update study documents when there are changes in study personnel/study amendments.
• Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.
• Update status reports, applicable logs, and tracking systems as applicable for the projects with input provided by senior staff.
• May support / assist the contract negotiation process under supervision of an experienced colleague or line manager.
• Proactively identify and escalate to Submission Leads any risk to meeting deliverables.
• Notify the Submissions Lead of hours identified as Out-of-Scope or over burn with the support of more senior specialists.

Clinical Trials Information System (CTIS) Tasks (Specific Centralized Role for EU)

• Upload of submission documentation to CTIS under supervision as applicable.
• Manage and may lead the day-to-day operations within relevant support function to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives.
• Manage and may lead functional and cross-functional internal teams.
• Provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools.
• Proactively identify and escalate issues that arise related to support functional deliverables.

Qualifications (Minimum Required)

• BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree.
• Experience (Minimum Required): Minimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
• Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines.
• Demonstrated basic understanding of the clinical trial process.
• Must have knowledge of clinical trial conduct, including, multi-center, global trials.
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Requires proven project management skills and leadership ability.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Fully fluent in English.

Pay Range

$27-30/hour

Benefits

All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable