FSP Study Start-Up Associate

Fortrea•Durham, CA

20h•$27 - $30•Onsite

About The Position

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. Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.

Requirements

BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree
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.
Fluent in English.

Responsibilities

Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.
Assist senior staff to compile, prepare, submit, and obtain 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).
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.
With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.
May support / assist the contract negotiation process under supervision of an experienced colleague or line manager.
Proactively identifying and escalating 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.
All other duties as needed or assigned.
Upload 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
Responsible for implementation of standards for designated functional areas
Responsible and may be accountable for all activities associated with relevant support function. This may include:
Manage Clinical Operations Compliance related activities inclusive of holistic evaluation of CO related audit findings, execution of CAPA and process related effectiveness checks, and CO inspection readiness support and/or
Manage Clinical Operations Vendor oversight/performance activities inclusive of vendor capability evaluation & selection, management of assigned vendors, planning/delivery of vendor governance meetings, analysis of key performance measures, vendor issue escalation etc. and/or
Manage and provide operational support of the global study operating model inclusive of development and maintenance/optimization of various CO business processes and service provider related operating models (CRO, IRT, Central Lab) and/or
Manage the sustainability and optimization of internal and external business process standards for Clinical Operations and/or
Manage and provide operational support related to systems and system/technology standards for the CO organization and/or
Management of CO QD changes and training related assignments/curriculum and staff onboarding activities
Provide oversight and direction to team members for functional and study-related deliverables
Participate in process improvement and quality-related initiatives associated with study execution and deliverables
Support and implement Study Start Up activities including global site and country level feasibility, site start up and activation, regulatory and ethics document preparation and submission
Responsible for the management of functional budgets and resources (where appropriate) and management of related components of trial or support function budgets, timelines and resources. May also provide oversight for these activities.