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Lead Clinical Research Associate

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Job Title: Lead Clinical Research Associate

Job Status: Full Time Exempt

Reports to: Vice President, Clinical Affairs

Location: Dallas, TX – Remote work may be an option

Amount of Travel Required: Up to 35%

Work Schedule: Full-time

Positions Supervised: None

 

Osteal Therapeutics:

Osteal Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a novel pipeline of combination therapies for orthopedic 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 late-stage clinical 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.

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Position Summary:

Osteal is looking for an experienced Lead CRA to coordinate important aspects of our current Phase 2 clinical program. Reporting to the VP, Clinical Affairs, the Lead CRA will be a critical member of the clinical team, providing oversight on the clinical quality, safety, and data monitoring of clinical trial programs 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:

  • Perform remote central monitoring to support data cleaning for ongoing clinical trials.

  • Perform quality site visits, including site and data review, and site team training to support clinical compliance and data integrity.

  • Perform and/or support on-site 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.

  • Manage process to ensure timely and appropriate adjudication, documentation, and tracking of clinical safety events and associated documents.

  • Coordinate safety review process with the Data Safety and Monitoring Board vendor, and Independent Medical Safety Monitor directly.

  • Perform site management activities at clinical trial sites, including IRB submissions and tracking, manage site communication, and ensure the timely collection, review, and tracking of required essential documents.

  • Work with other Clinical Affairs personnel to monitor key study site performance metrics.

  • Support site quality oversight and remediation including CAPAs and retraining efforts.

  • 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 support the review of clinical data quality and integrity, review data listings for accuracy and completeness, support data discrepancy management, and perform associated training/retraining to site staff as needed.

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

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Experience/Skills:

  • Bachelor’s degree with at least 8 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 monitoring or auditing all phases of pharmaceutical and/or medical device clinical trials.

  • Successful track record of performing or supporting clinical quality and safety in all phases of pharmaceutical and/or medical device clinical trials.

  • Experience in orthopedics strongly preferred.  Other Medical training and education may be considered.

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

  • Experience in IRB submissions.

  • 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 35%).

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