Job Description

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.

Job Tags

Similar Jobs