Provides project support to Pharmacovigilance Manager and/or Clinical Safety Specialist(s) and other project team members from proposal development through final deliverable.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
• Performs project related tasks which include remote data reviewing and summarizing data reports, designing study files, supporting Data Management in systems testing, and developing and distributing study newsletters
• Develops and maintains tracking reports related to progress of studies, communicating regularly with PM and team on status of activities
• Responsible for the set-up and administration of the safety database.
• In conjunction with management, develops and documents processes required to run clinical studies effectively
• Collaborates in the design, development and maintenance of study-related web pages
• Responsible for web portal accuracy and consistency
• Provides administrative support to projects as needed (e.g., taking minutes, copying, filing, faxing, filing, scheduling)
• Performs other duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
• Good knowledge of clinical research process
• Good written and verbal communication skills.
• Excellent organizational and interaction skills
• Experience in a team/matrix environment
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Ability to handle multiple priorities within multiple, complex clinical trials
• Ability to work independently
• Understanding of current GCP/ICH guidelines applicable to conduct of clinical research
• Extensive experience with Microsoft Word, Excel, and Power Point
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
• Very limited physical effort required to perform normal job duties.
MINIMUM RECRUITMENT STANDARDS:
• Associate’s Degree in one of the life sciences and a minimum of 2 years of direct clinical experience.
• Good verbal and written communication skills required.
• Excellent interpersonal and organization skills required.
• Ability to work independently, prioritize and work with in a matrix team environment required.
• Computer literacy required.
This position is exempt from the Fair Labor Standards Act; employees are not eligible for overtime compensation.
Novella Clinical - 18 months ago