Start-up Specialist

2 tygodni temu

Warsaw, Polska POL Fortrea Poland Sp z o.o. Pełny etat

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. 

Start up specialist is primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor. Proactively interacts with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements. Maintain awareness of current regulatory standards related to submissions. Serve as local expert in project start-up activities for a particular country or region. Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable.

Summary of Responsibilities:

• Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.

• Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable.

• Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval.

• Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).

• Perform a review of final submission documents as applicable.

• Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards.

• Prevent and 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 without supervision.

• 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.

• Participate in team and project meetings as applicable.

• When needed, assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams.

• Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.

• May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate.

• Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.

• Notify the Submissions Lead of hours identified as Out-of-Scope or overburn.

• Clinical Trials Information System (CTIS) tasks (specific centralized role for EU):

• Assist in the upload of submission documentation to, interacting with and monitoring of all notifications and alerts in CTIS to ensure all milestones and events for the trial are met within the timelines mandated.

Qualifications:

University Degree in Life Sciences or equivalent field. Fortrea may consider relevant and equivalent experience in lieu of educational qualifications.

 

Experience:

Minimum of 2 years of experience in clinical development or start-up/ regulatory process

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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