The Clinical Project Associate is an individual who support Project Management activities while developing clinical skills while working alongside the Clinical Operations team. As part of the project team coordinating deliverable for assigned projects. The Clinical Project Associate serves as the liaison with Business Development during Sales cycle, coordinates and participates in project kick-off meetings, provides regular updates to client, and ensures maintenance of communication between team members and client.
Essential Job Functions
- Support the project team on designated projects ensuring that customer service, quality, and timelines are met.
- Ensure the project is completed on-time and as promised (timelines, budget, etc.).
- Oversee projects as assigned and act as the primary interface between the client and the project team.
- Primary point of client contact for issue escalation, screening/enrollment questions and other project related issues.
- Coordinates activities among the functional departments (Regulatory, Quality, Clinical, Investigator, Recruitment) to ensure deliverable are on-time and as promised in the Clinical Trial Agreement.
- Ensures all communication, particularly in response to client requests, are timely and efficiently answered.
- Perform quality control checks to ensure the integrity of data.
- Aid in the preparation of document and specimen shipments, as needed.
- Assist with query resolution.
- Ensure proper filling of all study documents and communicate with client fielding, answering, and directing questions to obtain timelines and assess resource needs.
- Compiles project metrics/KPIs to measure project performance.
- Proactively anticipates and understands concerns/issues/delays in the project and develops contingency plans and related communication plan(s) to appropriate team members.
- Plans and manages the project.
- Holds each functional area responsible for deliverables and manages messaging to client throughout the course of the project.
- Primary source of communication for the project team to discuss and align milestone dates.
- Collaborates with the Business Development team to generate a project budget.
- Responsible for timely execution of change orders and related amendments.
Knowledge, Education, and Experience
- Bachelor’s degree preferred or related experience (in which case minimum of 2 year’s of experience strongly preferred).
- Knowledge of FDA, GCP, ICH and other state and federal agency guidelines.
- Knowledge of HIPAA Privacy Act and its application to clinical research.
- Knowledge of IRB requirements.
Job Category: Project Management
Job Type: Full Time
Job Location: Marlton