Precision for Medicine

Precision for Medicine

Senior Clinical Research Associate/Clinical Research Associate II - FSP

Remote, United States · Senior

Sponsorship not specified$92k-$137kDetected 5 days ago
GCPProject ManagementNegotiationContract ManagementEHR/EMRClinical TrialsClinical ResearchPharmacovigilanceResearchCommunicationPublic SpeakingOrganizational Skills

About the role

  • The CRA II is a seasoned, experienced professional in monitoring and site management.
  • will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management.
  • Incumbents work independently as a study team member.

Responsibilities

  • Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.

Requirements

  • Minimum Required:
  • Site management or equivalent experience in clinical research
  • Experience monitoring oncology trials
  • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
  • Ability to travel overnight.
  • Demonstrated ability to conduct formal presentations to a wide variety of audiences including, colleagues, investigative staff, and clients with a high level of proficiency
  • 4-year college degree or equivalent experience in a scientific or healthcare discipline.
  • Two (2) years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research
  • A valid driver's license and clean driving record
  • Other Required:
  • Excellent communication and organizational skills are essential. A team player.
  • Evidence of a client focused approach
  • Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed.
  • Fluency in English and for non-English speaking countries the local language of country where position based
  • Preferred:

Nice to have

  • Graduate or postgraduate degree
  • Auto-immune monitoring experience
  • Experience monitoring in rare and complex therapeutic areas
  • Experience monitoring EDC trials and EHR records
  • Experience in biopharma or relevant therapeutic area
  • Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
  • Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.

Compensation

  • Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.

Visa & Work Authorization

  • Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
  • Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
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