EMA Wellness provides a sponsor with the capability to capture multiple sources of patient information between scheduled visits within the parameters of the clinical study. The EMA Wellness technology combines interactive mobile technology to capture patient response information on a momentary basis for analysis. This information can supplement that collected in office visits and can also collect similar data between visits. The cloud based analytic system captures the data in an analysis ready format and can also be used to monitor adherence and get information from informants in real time as well.
The Project Specialist will be responsible for providing administrative and trial support to clinical projects thereby contributing to the cost efficiency and overall management of clinical trials in accordance with the standards of ICH-GCP and applicable local regulations and Standard Operating Procedures (SOPs). This position will report to a Senior Project Manager.
Specific Functions include:
• Interfaces with Client representatives and EMAW project teams
• Assists project teams with selective aspects of trial management from start-up to close-out on one or more projects.
• Provides support of maintenance tasks such as tracking and filing for the duration of the project, and with preparation for audits and archiving.
• Provides support with set-up, access requests, and maintenance for project systems (e.g. AX, CTMS, EDC, Shared Drive).
• Conducts trainings with sites and account users including application demonstrations, user account and subject registration instructions, device set-up instructions and portal/dashboard accessibility.
• Maintains and updates project-related data in an existing database, contacting internal team members to gather information.
• Assists with the preparation and distribution of project-related correspondence (e.g. agendas, meeting minutes, tracking spreadsheets, newsletters and presentations).
• Assists with the development of and updates to projects-related plans and site manuals
• Acts as primary in-house contact for site and CRA support in the receipt, collection, and tracking review of essential and non-essential documents and distribution of study-related communications.
• Reviews essential and non-essential documents from sites to ensure all required documents are accurate and complete.
• Coordinates translation of project documents acting as primary contact with translation vendor.
• Assists with the planning, organization and execution of meetings (e.g. project Kick Off meetings, internal team meetings, Client meetings).
• Assists with maintaining of project team lists.
• With PM oversight, leads periodic and ongoing review, management, and QC of project specific training records, reporting any missing records to the PM and functional project leads as appropriate. Assists in obtaining training documentation from project team members.
• Support project related vendor management activities.
• Executes and distributes reports from various systems
• Assists the PM with budget management including tracking out of scope items, performing timesheet or billing approvals in the system, following-up on billing queries and updating the system.
• Provide other project support to functional teams as directed by Line Management.
• Serve as mentor to Clinical Project Associates, as requested.
Requirements include:
• Degree in related field of study
• Two years of relevant working experience in the industry or equivalent
• Working knowledge of GCPs, ICH guidelines, FDA and applicated healthcare regulations preferred
• Proficient in MS Office programs
• Effective verbal and writing skills
