13 publicaciones de empleo destacadas en contract specialist (¡Están contratando!)

Site Readiness and Regulatory Specialist I
Fortrea —Buenos Aires, Buenos Aires
- Tiempo completo
Sr. Site Contracts Associate, IQVIA Biotech
IQVIA —Buenos Aires, Buenos Aires
- Tiempo completo
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EPAM Systems, Inc. —Desde casa
Services Specialist - Instrumentation and Control
GE Vernova —Rosario, Santa Fe
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Site Contracts Specialist with clinical trials experience Home-Based in Argentina
Syneos - Clinical and Corporate - Prod —Desde casa
- Tiempo completo
2d
Contracting Risk & Independence Senior Manager - US Client
PwC —Buenos Aires, Buenos Aires
- Tiempo completo
Project Management Analyst - Tax - US Client
PwC —Partido de Vicente López, Buenos Aires
- Tiempo completo
Senior Commercetools Developer
Globant Commerce Studio —Buenos Aires, Buenos Aires
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Site Contracts Specialist with clinical trials experience Home-Based in Argentina
サイネオス・ヘルス —Buenos Aires, Buenos Aires
2d
Alliances Reporting Operations Specialist (SAP) - EY Global Delivery Services
EY —Capital Federal, Buenos Aires
Alliance Reporting Operations (Microsoft) - Assistant Director - EY Global Delivery Services
EY —Capital Federal, Buenos Aires
Motion Designer - DaVinci Resolve (German-speaking)
Obsidian Group —Buenos Aires, Buenos Aires
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Office Operations Specialist
TELUS Digital —Buenos Aires, Buenos Aires
- Tiempo completo
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Sr. Site Contracts Associate, IQVIA Biotech
IQVIA —Buenos Aires, Buenos Aires
3-5-year relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable global and/or regional experience…
Project Manager (Argentina)
Indero —Desde casa
Oversee activities related to sites selection (feasibility questionnaires, sites selection, planning of site qualification visits).
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Site Readiness and Regulatory Specialist I

Fortrea -
Buenos Aires, Buenos Aires

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Detalles del empleo

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

Summary of 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).
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.
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.
Clinical Trials Information System (CTIS) tasks (specific centralized role for EU):
Upload of submission documentation to CTIS under supervision as applicable.

Qualifications (Minimum Required):

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

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.

Physical Demands/Work Environment:

General Office Environment.

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Site Readiness and Regulatory Specialist I

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