TITLE AND CLASSIFICATION: Clinical Study Coordinator
REPORTING LOCATION: Rockville, MD
REPORTS TO: Head of Clinical Operations
SCHEDULE: 7:00 AM - 3:30 PM/Weekend on call work may be necessary
PRIMARY OBJECTIVES
The Clinical Study Coordinator (CSC) serves as the primary supporting role for the Clinical Operations team who manage Champions Clinical Trial Services. The CSC will work closely with the Project Leaders/Study Directors and requires strong communication skills, attention to detail and the need to be highly organized. The CSC manages time-sensitive clinical sample processing, tracking, and documentation within strict timeframes. This role serves as the primary coordinator for sample management, kit logistics, and data entry, requiring exceptional attention to detail, strong time management, and the ability to handle multiple concurrent priorities. The CSC will also interact and liaise with various internal operations groups at Champions to coordinate the scheduling/planning and execution of studies as well as external sites and CRO’s regarding clinical sample shipment notifications, scheduling, or kit orders.
DUTIES AND RESPONSIBILITIES.
To support the Clinical Operations team, duties and responsibilities will include:
- Enters all samples for clinical trials into the LIMS.
- Verify and reconcile sample documentation against physical samples as needed
- Manage urgent sample discrepancy resolution and follow-up
- Handle customs documentation and courier coordination
- Schedules clinical samples shipments from sites to Champions and monitors tracking/scheduling.
- Assists with entry of study information into database(s) for project management purposes.
- Assists in generating initial study timelines and project kick off documentation.
- Creates Clinical Sample protocol drafts and data transfer agreements forms.
- Works with logistics to receive clinical samples and organizes shipment of samples to the client or vendors as needed.
- Clinical sample kit management: assisting in kit setup for trials, scheduling kit shipments, and inventory management.
- Assists with other functions such as revenue recognition, project management, sample inventory, samples discrepancies, and data reconciliation as needed.
- Assists with secure data delivery study data at regular intervals and at completion of client studies.
- Writes, revises, and reviews SOPs as needed.
- Identifies and provides resolution to problems involving ongoing studies, as appropriate.
- Participates and provides feedback in team meetings.
- Works independently and performs other related duties as assigned.
