Clinical Research Associate

Job Title:          Clinical Research Associate

Reports to:       Vice President, Clinical Affairs

Location:          Dallas, TX – Remote work may be an option for those unable to relocate

 

Position Summary:

Osteal Therapeutics, Inc. is a clinical-stage company developing a novel pipeline of drug/device combination therapies for the treatment of musculoskeletal infections and their consequences. Our lead investigational candidate, VT-X7 was granted Orphan Drug, FastTrack and Qualified Infectious Disease Product designations by the FDA and is currently in Phase 2 comparative trials for the treatment of Periprosthetic Joint Infection (PJI). With a robust pipeline of additional indications and therapeutic candidates, we anticipate rapid and sustained growth.

Osteal is looking for an experienced Clinical Research Associate (CRA) to coordinate important aspects of our current Phase 2 clinical program. Reporting to the VP, Clinical Affairs, the CRA will be a critical member of the clinical team, providing oversight on the implementation and data monitoring of a robust clinical trial program to support Osteal’s current and future products. This is an opportunity for an experienced research professional to play a central role in executing trials that will be critical to Osteal’s success.

 

Essential Responsibilities:

  • Manage site start-up activities at clinical trial sites, including IRB submissions, and ensure the timely collection and review of required essential documents.

  • Perform clinical monitoring activities, including site initiation, interim monitoring and close out visits, and completion of associated reports.

  • Contribute to the development of Clinical Affairs SOPs, best practices, work instructions, tools, and templates.

  • Work with Clinical Trial Manager to monitor key study site performance metrics.

  • Assist in the development of trial materials as needed (e.g., protocols, case report forms, monitoring guidelines, site tools, and training guides).

  • Work with other Clinical Affairs functions to review the quality and integrity of the clinical trial data, review data listings for accuracy and completeness, oversee data discrepancy management, and perform associated training/retraining to site staff as needed.

  • Create and manage systems with outside vendors to ensure appropriate documentation and storage of clinical trial documents.

  • Responsible for investigational product inventory control and accountability.

  • Review progress of projects and initiate appropriate actions to achieve target objectives.

  • Organize clinical trial meetings and deliver presentations as required, both at in-person and online meetings.

  • Participate in writing clinical trial reports as assigned.

Experience/Skills:

  • Bachelor’s degree with at least 5 years of relevant clinical research experience in industry or at a clinical research center.

  • Strong working knowledge of FDA and ICH/GCP regulations, and thorough knowledge of clinical monitoring procedures.

  • Successful track record of coordinating all phases of pharmaceutical and/or medical device clinical trials.

  • Experience in orthopedics preferred but not required.

  • Experience with Trial Master File management.

  • Experience using eTMF, EDC, CTMS, and other vendors systems/portals.

  • Experience in IRB submissions and site budgeting/contracting.

  • Experience in working with and managing CROs.

  • Self-starter with good written and oral communication skills.

  • Ability to multi-task and prioritize tasks according to trial needs.

  • Willingness and ability to travel regularly (up to 20%).