Clinical Research Associate at ZimVie US Corp LLC Palm Beach Gardens, FL
Behavioral Health Market Context
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Qualifications
- •Expected Areas of Competence (i.e., knowledge, skills, and abilities)
- •Ability to foster positive working relationships with a wide variety of internal and external personalities
- •Demonstrates a drive for continuous learning and continuous improvement
- •Balances an attention to detail with the overarching strategy
- •Proficient in Microsoft Office Suite
- •Knowledge of regulations governing clinical studies including GCP (Good Clinical Practices), PHRP (protecting human research participants), and HIPAA principles
- •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
- •4 more items(s)
Responsibilities
- •Responsible for supporting study management and data reports for clinical trials being conducted by the Scientific Affairs team
- •Clinical study responsibilities include tracking and communicating the ongoing operation performance of each active study and study site
- •Additional areas of responsibility include supporting business needs in the areas of new product development teams, extended claims, and operation/execution of new clinical trials
- •This role reports to the Scientific Affairs Manager and primary responsibilities include:
- •Assists the trial manager in all aspects of trial development and initiation such as contract management, payment tracking, remote monitoring, study binder management and regular reporting to all active sites
- •Case report form (CRF) development and revision as necessary
- •Maintenance of the Sponsor’s Trial Master File
- •Remote data quality monitoring and query resolution with Site(s)
- •Enrollment, intervention, and follow-up tracking of all study patients
- •Coordinates all regulatory activities for both active and future investigators under the direction of the Scientific Affairs Manager
- •May perform onsite monitoring activities either independently or in conjunction with the trial manager or contract monitor
- •Assists the trial manager with the review and compilation of data and prepared reports as needed for regulatory agencies, IRBs, investigative sites, or notified bodies
- •May assist or independently perform literature reviews as needed for protocol development, complaint handling, new product development, or in support of regulatory submissions
- •This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA
- •11 more items(s)
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