Responsible for supporting study management and data reports of clinical trials conducted by the Zimmer Biomet Spine Clinical Affairs team, ensuring compliance with Zimmer Biomet policies and procedures. Clinical study responsibilities include tracking and communicating the ongoing performance of each active study and study site. Additional areas of responsibility include assisting with data management of clinical trials and quality control of patient data.
Principal Duties and Responsibilities
This role reports to the Clinical Affairs Manager with the primary responsibilities below:
Supports Clinical Affairs Manager/Senior Clinical Research Associate with all aspects of trial development and initiation such as protocol, case report form, and site materials development, corporate compliance approvals, contract negotiation and tracking, collection and filing of essential documents, and site initiation
Coordinates with sites the institutional review board approvals, amendments, continuing reviews, reporting, and closure
Supports and tracks subject enrollment, follow up, and adherence to protocol follow up windows
Maintains the sponsor’s Trial Master File
Performs routine data cleaning, assists with query communication and resolution
May perform onsite monitoring activities either independently or in conjunction with the Clinical Affairs Manager/Senior Clinical Research Associate or contract monitor
Assist with preparation of invoices and payment tracking
Expected Areas of Competence
Ability to foster positive working relationships with a wide variety of internal and external personalities.
Demonstrates a drive for learning and working under SOPs, continuous learning and continuous improvement
Balances an attention to detail with the overarching strategy
Proficient in Microsoft Office Suite
Knowledge of FDA regulations and guidance governing clinical studies including 21 CFR 812, 50, and 56, ICH GCP (Good Clinical Practice), and HIPAA
Capable of learning new software packages as required
B.S. Degree in the health, life sciences, or engineering disciplines, or equivalent experience plus 3-5 years experience working in a clinical research environment, or an equivalent combination of education and experience.
Up to 35%