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Open nowPosted 16 days ago

FSP Sr. Clinical Scientist - Immunology

Fortrea49 open roles

Where
Durham
Work mode
Remote
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Your applicationOpen nowFSP Sr. Clinical Scientist - ImmunologyFortrea · Durham

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The clock on this job

Early applications get read.

8.1% of postings close within 7 days. Measured by our own scanner across the market. Fortrea postings stay open a median of 4 days.

Share of postings closed within
  1. 1.7%1 day
  2. 3.6%3 days
  3. 8.1%7 days
  4. 15.1%14 days
  5. 34.0%30 days
This job: posted 16 days ago

Fortrea median: 4 days open

The posting

Senior Clinical Scientist, FSP – Immunology – Remote US or Canada

***Position leads Phase 1-3 Clinical Trials and oversees medical monitoring.

This is not a laboratory/research scientist role.***

In this role, the selected candidate will lead/support studies; be accountable for the clinical/scientific execution of the protocol; be the clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites); and act as scientific lead on Clinical Trial Team (CTT).

Responsibilities include:

  • Responsible for trial design and endpoint development in collaboration with CD; collaborates with medical writing to develop trial results communication for investigators
  • Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports, monitoring data issues and central lab reports
  • Sets up/supports SAC, DMC, adjudication committee; provides scientific input to SM for data management activities (e.g. EDC, DRP, CRF’s_
  • Protocols/amendments – collaborates with medical writing, participates in governance committee review; authors protocol clarification letters; reconciles and reviews all protocol deviation classifications and assess and prepares protocol deviation list for the CSR
  • May act as mentor to other Clinical Scientists

Requirements:

Education:

  • Degree in Life Sciences or significant experience in clinical development (>14 years)
  • BS/BA with 7+ yrs clinical research experience
  • MS/PhD with 5+ years clinical research experience

Experience:

  • Minimum 2 years pharmaceutical and clinical drug development experience in a Clinical Scientist role as a lead required.
  • Proven ability to effectively manage multiple complex studies
  • Medical monitoring experience required
  • TA-specific experience in Immunology
  • Excellent Excel and PP skills required
  • Excellent written and oral communication skills

Target Pay Range for US: $135-150K

Physical Demands/Work Environment:

Work Environment:

  • Work is performed in an office environment with exposure to electrical office equipment.
  • Frequent travel to clients/ site locations with occasional travel both domestic and international.

Physical Requirements:

  • Ability to sit for extended periods and operate a vehicle safely.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Regular and consistent attendance.
  • Varied hours may be required.

Learn more about our EEO & Accommodations request here.

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