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The Clinical Operations Administrative Assistant will effectively complete clinical trial related duties and administrative tasks to support to the Clinical Operations team.
Perform clinical trial related assistance:
• Assemble and distribute documents to clinical sites, including study material binders, ex., Source Documents, Manual of Procedures and Scar Manipulation Logs
• Assist with preparation of clinical materials shipments to clinical sites, including Subject ID labels, Final Product packaging labels
• Facilitate execution and filing of clinical contracts
• Work with Accounting to track and assist in managing HCP reimbursements for Sunshine Act
• Assist in managing patient reimbursement programs for STRATA2014 & STRATA2016, ex., Purchase gift cards, track gift card use for accounting purposes and assist in distributing to sites
• Manage clinical equipment inventory
• Maintain and update clinical site contact files
• Assist in overseeing the travel nurse program. Assist in developing procedures for use of the Travel Nurse, manage materials provided to nurses for patient travel, communicate with nurses on training status, and respond to inquiries from nurses. Provide travel arrangements for clinical study sites.
• Manage and purchase supplies required for clinical materials shipments
• Assist with preparation and managing meeting details for Site Initiation Visits (SIV) and Investigator Meetings
• Coordinate meetings with clinical vendors and generate minutes
Perform administrative duties to support the Clinical Operations Team:
• Assist with coordinating logistical details for SIVs, Investigator Meetings, conferences, travel to patient surgeries, etc.
• Help manage detailed calendars for team members travel, and assist with travel arrangements
• Provide meeting support activities (room reservations, hospitality, audio/visual set-up, minute taking)
• Assist in generation of expense reports
Department specific/Non-essential responsibilities:
• Complete required ComplianceWire Training sessions
Experience / Skills:
• Minimum Associates Degree
• Web-based scheduling and/or teleconferencing systems
• Experience with online Corporate Travel and Expense systems
• Clinical Operations experience and experience in biotech or healthcare field preferred
• MS Office
• Ability to handle multiple projects simultaneously and work in a fast-paced environment
• Strong written and verbal communication skills
• Problem assessment and problem solving skills
• High level of attention to detail and accuracy
• Ability to work as part of a team
• Manage administrative processes proficiently
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We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion, color sex, national origin, citizenship status, age, sexual orientation, gender identity, marital status, uniform service member status, genetic information, disability, or any other protected status, in accordance with all applicable federal, state, and local laws. This practice extends to all aspects of our employment practices, including but not limited to, recruiting, hiring, firing, promoting, transferring, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.
Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States. Our organization participates in E-Verify.
EEOC and E-Verify