Position Summary
HALO Precision Diagnostics seeks a visionary Clinical Research Manager to lead and innovate in clinical research initiatives across advanced imaging modalities. This role is critical for driving the execution of investigator-initiated research (NCT 02243033), managing the Laser Focal Therapy Registry, overseeing surgical case support, training staff, and directing sponsor-initiated studies in an outpatient imaging setting. The ideal candidate will blend strategic leadership with operational excellence to advance precision diagnostics and therapeutic outcomes.
Key Responsibilities
1. Investigator-Initiated Research (NCT 02243033)
• Lead the execution of the clinical trial (NCT 02243033), ensuring protocol adherence, regulatory compliance, and timely follow-up.
• Manage data analysis timelines, and reporting to institutional review boards (IRBs) and stakeholders.
2. Laser Focal Therapy Registry Management
• Develop and maintain a robust registry database for tracking patient outcomes, adverse events, and long-term efficacy of laser focal therapies.
• Collaborate with physicians and research team to ensure high-quality data collection and analysis.
3. Surgical Case Support & Imaging Integration
• Provide support for laser focal therapy cases, including preop and informed consent .
• Document procedural outcomes and contribute to post-operative follow-up protocols.
4. Staff Training & Development
• Coordinate delivery of training for research coordinators, data managers, and imaging technicians.
• Foster a culture of continuous learning in advanced imaging techniques (MRI, CT, PET/CT) and research ethics.
5. Sponsor-Initiated Research Oversight
• Serve as the primary liaison for industry-sponsored trials, ensuring alignment with HALO partners' operational standards and imaging capabilities.
• Participate in contract reviews, monitor site performance, and ensure audit readiness.
6. Regulatory & Compliance Leadership
• Ensure compliance with FDA, GCP, HIPAA, and institutional policies.
• Prepare for audits and lead CAPA initiatives as needed.
7. Cross-Functional Collaboration
• Partner with radiologists, surgeons, and AI/ML teams to integrate imaging data into predictive analytics models.
• Present findings at conferences and publish results in high-impact journals.
Qualifications
• RT, RN or equivalent in Biomedical Sciences, Radiology, or related field.
• Experience: 5+ years in clinical research leadership, with oncology/imaging expertise.
• Certifications: CITI, GCP, and IRB training required.
• Skills:
• Understanding of imaging modalities (MRI, CT, ultrasound).
• Proficiency in REDCap, Medidata, or similar clinical trial platforms.
• Exceptional communication and project management abilities.
Preferred Qualifications:
• Experience with laser ablation therapies or focal therapy registries.
• Track record of contributions to or authorship of peer-reviewed publications in precision diagnostics.
Work Environment
• Setting: Outpatient imaging center with state-of-the-art technology.
• Travel: <10% for conferences or collaborator meetings.
• Physical Requirements: Ability to stand for extended periods during surgical cases and operate imaging equipment.
About HALO Precision Diagnostics
HALO pioneers precision diagnostics through cutting-edge imaging and AI-driven analytics. Our outpatient centers specialize in minimally invasive therapies, leveraging multimodality imaging and advanced biomarkers to personalize cancer care. Join us in redefining the future of precision medicine.
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