Senior Clinical Scientist

Location
Raleigh, North Carolina (US)
Salary
Competitive salary and benefits
Posted
Aug 29, 2018
Closes
Sep 18, 2018
Education
BS, PHD
Hours
Full Time

Senior Clinical Scientist 2018- 47832

 

This position is responsible for the scientific conduct of a protocol. Assists the Program Lead and study team with the scientific conduct of clinical studies. May have specific task assignments for a single study or across multiple studies, e.g, adjudication support, medical monitoring, data management deliverables, preparation of meeting materials, safety and medical monitoring. May interact with internal and external stakeholders (study sites, committees, etc) in support of clinical study objectives. Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)

 

  • Responsible for trial design and endpoint development in collaboration with CD
  • Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports
  • Authors protocol clarification letters
  • Contributor to study specific documents (e.g., SMP)
  • Monitors central lab reports and other external data for safety and critical values
  • Prepares scientific slides, attends and presents protocol information at Investigator Meeting
  • Scientific lead on Clinical Trial Team (CTT)
  • Reconciles and review all protocol deviation classifications in SPECTRUM
  • Assesses and prepares protocol violator/deviation list for CSR
  • Collaborates with MW to develop trial results communication for investigators

Requirements

  • Degree in the Life Sciences or significant experience in clinical development (> 11 years)
  • Oncology experience required 
  • Bachelor’s degree with 7+ years’; or MS with 5+ years’; or PhD with <2 years’ relevant career experience
  • Pharmaceutical and/or clinical drug development experience.
  • Excellent oral (including presentation) and written communication, computer/ database management and project management skills

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

Apply Directly to Kristen Reisenauer at ReisenauerKristen@prahs.com