Job Description

Work ScheduleEnvironmental ConditionsDescription

• Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CTM.
• Liaises with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor. Plays an active role on the project team to help ensure compliance with monitoring visit report expectations.
• Reviews and customizes the Monitoring Report Templates for allocated projects.
• Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess sites ability to conduct study, as ascertained from information noted in monitoring visit reports and associated electronic data systems.
• Attends applicable internal Project meetings.
• Provides input of forecast estimates for report review activities.
• Provides trial MVR status tracking and progress update reports to team as required.
• Contributes to company, client, and federal/local regulatory requirements/audit responses as needed.
• May perform support activities to the team as agreed on allocated projects.

• Bachelors Degree in a life science-related field or relevant/equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
• Prior clinical research experience with a minimum of 2 years on site clinical monitoring.
• Good therapeutic area knowledge and understanding of medical terminology by virtue of past training of a CRA
• Ability to attain and maintain a working knowledge of FDA and/or local country regulation and guidelines, ICH GCPs and PPD procedural documents
• Ability to successfully complete PPDs Clinical Foundation Training Program (CFP)
• Highly effective oral and written communication skills with the ability to communicate effectively with project team members
• Excellent organizational and time management skills
• Ability to work in a team or independently or as home based, as required
• Ability to write clinical monitoring visit reports, review or approve them and interpret the information captured in clinical monitoring visit reports
• Ability to extract pertinent information from protocols, electronic study data systems, CTMS, dashboards and assess risk at site level through interpretation of all these data
• Excellent English language and grammar skills
• Ability to mentor junior team members, as needed

Thermo Fisher Scientific