Clinical Research Associate

areas of responsibility include supporting business needs in the areas of new product development teams, extended claims, and operation/execution of new clinical trials.

Principal Duties and Responsibilities:

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. Ongoing responsibilities to include:

  • 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.

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

Education/Experience Requirements

• 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.

Travel Requirements

Up to 35%

1. #LI-Remote

ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, demotion, evaluation, compensation, and separation, are considered without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender/sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status, protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state and local laws.

ZimVie generally does not sponsor applicant work visas for this position.

• Requisition ID: 2926