Offer summary

Qualifications:

University/College degree in life science or related field, or equivalent certification., Minimum 2 years of experience in clinical research or start-up/regulatory processes., Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations., Familiarity with investigator start-up documents and contract/budget negotiation..

Key responsibilities:

Serve as a local expert in project Start-Up Activities for Portugal.

Coordinate and collect essential documents required by regulatory authorities.

Negotiate contracts and budgets with sites, preferably in Portugal.

Act as the primary contact for investigative sites, ensuring timely document collection.

Job description

Join Fortrea as Site Navigator and serve as a local expert in project Start - Up Activities for Portugal!

Responsibilities:

Preferable Site Identification experience / Feasibility.
Contract and budget negotiation with sites minimum 1 year (preferable sites in Portugal)
Coordinate, collect essential documents and organize data and information required by EC/Third body/Regulatory Authority according to regulatory legislation, guidance, and practice in the assigned countries.
Preferable PSV remote experience.
Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.

Experience Required:

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

• Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines.

familiarity with investigator start-up documents and contract/budgets negotiation process.

previous interaction with operational project teams and investigative sites.

• Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.

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) AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

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