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Lead Clinical Research Associate (Lead CRA)

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Job Title: Lead Clinical Research Associate (Lead CRA)

Job Status: Full Time Exempt

Reports to: Director, Clinical Affairs

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

Amount of Travel Required: Approximately 50% (up to 80%)

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 programs, as well as future trials. Reporting to the Director, Clinical Affairs, the Lead CRA will be a critical member of the clinical team, providing oversight on 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 clinical monitoring activities (on-site and remote), including site qualification, site initiation, interim monitoring and close out visits.

  • Complete high quality site visit reports and letters within specified timelines. 

  • Assess and improve monitoring strategies and methodologies; both on-site and remote.

  • Perform remote central monitoring to support ongoing data cleaning.

  • Perform quality site visits to assess overall site compliance and site staff assessment, including team training, to support clinical compliance and data integrity, as well as inspection readiness.

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

  • Manage and improved current 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 for clinical trial sites, including IRB submissions and tracking, Protocol and ICF review, manage site communication, and ensure timely collection, review, and tracking of required essential documents.

  • Work with other Clinical Affairs personnel to monitor key study site performance metrics, develop training material, and implement mitigation plans.

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

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

  • Work with other Clinical Affairs functions to support the development of study plans and guidelines, 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.

  • Create, update, and manage site visit report and letter templates; review and approve site visit reports; train other CRAs.

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

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Experience/Skills:

  • At least 8 years of relevant clinical research experience in industry or at a clinical research center with minimum of 5 years of experience in clinical site monitoring.

  • Bachelor’s degree or higher, preferably in medical or scientific discipline.

  • Strong working knowledge of FDA guideline 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.

  • Demonstrated proficiency of Microsoft Office applications.

  • Experience in IRB submissions and essential document review.

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

  • Strong organizational and time management skills.

  • Ability to multi-task, prioritize tasks, problem-solve, and demonstrate adaptability.

  • Must be comfortable at small fast-paced company with tight deadlines.

  • Willingness and ability to travel regularly (approximately 50%, up to 80% when needed)

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