CRA/ Clinical Project Manager (20-00041) – MA – Marlborough

Responsible for the conduct and management of clinical study activities  Works independently to complete CRA functions associated with study planning, implementation, monitoring and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).

Responsibilities

  • Conducts most aspects of site management and independently monitors study activities according to Client Standard Operating Procedures, ICH GCP guidelines and Regulations.
  • Conducts study risk assessments and applies the principles of risk-based monitoring.
  • Communicates with investigators and site staff across multiple studies.
  • Establishes key performance indicators prior to study initiation, and provides input into corrective action for study performance issues.
  • Study Implementation: Drafts and finalizes associated documentation and independently manages one or more projects including:
  • Study training presentations for investigators and site staff.
  •  Study supply ordering and shipping.
  • Investigational product release, labeling, accountability at study sites.
  • Site Readiness and Site Monitoring Plans.
  • Study records including site and trial master files.
  • Site qualification, site initiation, routine monitoring and close out visits and reports.
  • Document compilation for clinical study reports and document archive activities.
  • Data management activities including user acceptance testing, data entry, and data verification as needed
Education:
Bachelor of Science, RN or BSN preferred ; OR equivalent combination of education and clinical experience.
 
Experience:
  • 4+ years clinical research experience.
  • 2+ years of in-house CRA experience 
  • Extensive background in biomedical/healthcare services with laboratory experience preferred.
  • Familiar with good documentation practices, record retention requirements, and processes to assess, qualify, initiate, monitor and close investigational sites.
  • Knowledge, Skills and Abilities:
  • Knowledge of current Good Clinical Practices (cGCP) and Regulations.
  • Proficient with standard software applications (word processing, spreadsheets, presentations) as well as Microsoft Visio and Microsoft Project.
  • Excellent written and verbal communication skills.

Source: Job Diva – Job Listing

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