Site Management Associate I at PSI CRO AG

Job Description

• Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.

Site Management

• Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team
• Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
• Assists with handling administrative financial tasks
• Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections

Other Communication

• Exchanges data, documents, and other information with the project team and other departments
• Provides assistance with organization of internal team meetings
• Prepares draft minutes of internal team meetings
• Assists with preparation, attendance and follow-up of Investigator’s Meetings, as applicable
• Under supervision, maintains study-specific and corporate tracking systems

Document Management

• Maintains Trial Master File (TMF)
• Perform TMF review and oversight at country and site level
• Prepares, distributes, and updates Onsite Study Files (OSF) and OSF checklists
• Provides assistance with translations

Safety Management

• Ensures proper safety information flow with investigative sites

Other Assistance

• Provides miscellaneous administrative project support (if applicable)

Qualifications

• College/University Degree (Life Sciences)
• Prior experience of work as Nurse or Pharmacist
• Prior administrative experience in Clinical Research / CRO environment, preferably in an international setting, is a plus
• Proficiency in standard MS Office applications
• Good organizational and planning skills, problem-solving abilities, flexibility
• Detail-oriented, able to multi-task and work effectively in a fast-paced environment
• Team-oriented with excellent customer service and interpersonal skills, including a positive attitude to tasks and projects