8 days old

Clinical Research Associate (682662)

Zimmer Dental, Inc.
Palm Beach Gardens, FL 33410
  • Job Code

Job Summary

Zimmer Biomet Dental is a global leader in implant and restorative dentistry solutions with more than 60 years of industry experience. We are proud to be part of one of the largest musculoskeletal companies in the world. Our mission is to alleviate pain and improve the quality of life for people around the world. Every 10 seconds, 24 hours a day, and 7 days a week patients around the world receive a Zimmer Biomet product, resulting in helping millions of people each year. #ZBDental

The Clinical Research Associate will oversee and support the conduct of clinical studies, with a primary focus on the conduct of on-site and remote clinical site monitoring and centralized data review. Additional responsibilities may include, but are not limited to:

  • Study management tasks of site qualification

  • Contract and budget negotiations

  • Preparation and presentation of committee documentation

  • Study initiation including pre-monitoring, tracking, organizing, filing and maintaining study related documents, and maintaining IRB approvals in accordance with applicable compliance regulations and standards (i.e. GCP, ICH, ISO, FDA and MDR).

Principal Duties and Responsibilities

  • Support Clinical Study Site Management:

  • Conduct site visits (SQV, IMV, COV) as required per Monitoring Plan to perform source data/document verification

  • Complete clinical study site visit reports

  • Conduct centralized data review activities to identify potential outliers and discrepancies and communicate with sites to resolve data discrepancies and queries

  • Identify and assess suitability of clinical study sites and investigators

  • Clinical study product and material accountability

  • Close out clinical study sites on completion of the study

  • Prepare site subject binders, study visit documents and PowerPoint presentations

  • Additional study management activities may be assigned, including, but not limited to:

  • Preparation and presentation of documentation for internal committee review and approval

  • Budget preparation and negotiation of contracts with sites

  • Support and coordination with PI on IRB/EC review

  • Will primarily be responsible for non-regulated clinical studies, but may be introduced to regulated study activities as appropriate

  • Support and assist with Clinical Research Management:

  • Maintain study requirements for posting to clinical trials.gov

  • Maintain and update clinical study management systems as needed

  • Maintain completeness of site documents in trial master file

  • Able to assist in the creation and maintenance of the study annual budget

  • Able to create and edit a study report (annual or Ad hoc) as needed

  • Assist other team member participating in the cross-training opportunities with study-related activities

  • Support Process Management:

  • Works with team members to identify process improvements

  • Participate in regional and global process improvement initiatives

  • Maintain standard operating procedures

  • Actively participates in departmental and business unit meetings and scheduled activities

  • Willing to assist and mentor other team members

  • Ability to effectively identify and resolve conflicts and disagreements regarding clinical research matters

  • Impacts project teams and business units through quality work and leadership of projects or portions of projects

Expected Areas of Competence

  • Demonstrates a collaborative and positive attitude

  • Excellent communication and interpersonal skills; ability to manage difficult conversations with co-workers, clinical sites and investigators

  • Able to identify problems and research possible solutions

  • Willingness to assist others with job assignments and/or responsibilities

  • Excellent time management and organizational skills; attention to detail a must

  • Willingness to learn and progress

  • Able to think fast and act decisively

  • Must be able to function independently with manager or team members, and work without supervision

  • Conducts self in a compliant and ethical manner; Interactions with business partners (internal and external) are ethical and transparent

  • Strong change management and adaptability to new procedures and processes

Education/Experience Requirements

  • Bachelors Degree (or non-US equivalent), required; concentration in nursing, life sciences, engineering or other medical sciences preferred

  • A minimum of 3 years of applicable experience required, including a minimum of 1 year of field monitoring experience

  • Established knowledge of Good Clinical Practice (GCP) and local government-related guidelines and regulations

  • Clinical Research Professional certification is preferred

  • A combination of education and experience may be considered

Travel Requirements

  • Up to 30%

Additional Information


At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

Posted: 2021-06-08 Expires: 2021-07-07
Sponsored by:
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Sponsored by:
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Clinical Research Associate (682662)

Zimmer Dental, Inc.
Palm Beach Gardens, FL 33410

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