Manages clinical research imaging and post-visit data activities, including data uploads, quality checks, query resolution, database lock support, source corrections, adverse event escalation, and trial documentation. The role ensures GCP and ALCOA+ compliance, coordinates with cardiology and sonography teams, maintains project records, and trains or mentors sonographers. Candidates must hold dual cardiac and vascular registrations and have sonography plus clinical trial data management experience.
About Us
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. Hawthorne leverages convenient, trusted, healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs. By embedding high-quality research within local communities, Hawthorne makes clinical trials more accessible and convenient for patients. Our community-based model shortens timelines and helps bring better treatments to market, faster.
About the Role
This role will perform data management activities for clinical research projects in accordance with Good Clinical Practices and all applicable procedures, guidelines, laws and regulations. The Clinical Imaging Quality and Data Compliance Analyst role is an integral role designed to provide project support to the clinical operations team. This role directly reports into the Clinical Research Manager(s) and with oversight from the Director of Clinical Research Operations.
What You'll Be Doing | The Role
- Ensuring the data from visits is uploaded to the Hawthorne platform within a specific timeline.
- Reviewing project data within a specific timeline and delivering data in a timely manner to key stakeholders.
- Communicate to in house Cardiology and sonography teams on timelines expectations.
- Requesting and managing source/data corrections as needed.
- Uploading/entering data to third-party platforms (e.g., uploading echo images).
- Reviewing and resolving data queries.
- Participate in database lock activities.
- Perform a regular review (quality check) of data.
- Reviewing data for completeness and data quality/integrity (ALCOA+).
- Escalate or mitigate data issues according to Hawthorne standards.
- Ability to work with multiple different software programs.
- Assisting in the identification of potential adverse events.
- Notifying the appropriate stakeholders of potential adverse events in accordance with safety reporting timelines.
- Maintain project documents and project TMF
- Train, mentor, coach other sonographers
Post-Visit Data Management:
What You Bring | The Person
- Dual registered: cardiac and vascular required
- Bachelor’s degree in a life sciences-related field preferred.
- 2-4 years of sonography experience.
- 1-2 years of clinical trial and data management experience.
- Knowledge of Good Clinical Practices (GCP).
- Strong skills in the use of technology, tools, operating systems, and software.
- Strong organizational skills with experience balancing priorities and resources.
- Strong attention to detail is a must.
- A creative and resourceful problem-solver with strong critical thinking skills.
- An expert at planning, anticipating challenges and opportunities, and proactively taking steps to either avoid issues or operationalize new ideas.
- Able to work thoughtfully and decisively, anticipating the need to involve others, to foster an inclusive work environment that avoids unnecessary “fire drills” or “chaos.”
- Experience with electronic data capture (EDC) systems, including Oracle Clinical and/or Medidata Rave, preferred.
- Experience training sonographers, preferred
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