HEATHER AUSTIN
Clinical Research Director
Macomb,MI
Summary
Results-driven Clinical Research Site Director with expertise in oncology operations and multi-site oversight. Led regulatory compliance initiatives and quality management efforts, while mentoring teams to enhance performance. Developed strategic plans and optimized resource allocation to ensure efficient study execution.
Overview
13
13
years of professional experience
Work History
Clinical Research Site Director - Oncology
Profound Research
Troy, MI
04.2024 - 11.2025
- Oversaw study start-up, execution, and close-out across a diverse oncology portfolio.
- Led strategic and daily operations across multiple oncology research sites ensuring protocol adherence and regulatory readiness.
- Collaborated with investigators, sponsors, CROs, QA, and executive leadership to eliminate operational barriers, enhancing site performance.
- Created and executed SOPs to standardize workflows, ensuring compliance and consistency across research sites.
- Mentored site leadership and research staff, fostering a collaborative, high-quality culture.
- Oversaw budgets and resource allocation, aligning operational forecasting with project goals.
- Supported audits, inspections, monitoring visits, and CAPA implementation.
Clinical Research Site Manager
Profound Research
Troy, MI
09.2023 - 04.2024
- Acted as primary liaison to investigators, sponsors, and vendors, facilitating effective communication and collaboration.
- Supervised staff performance and training to ensure inspection readiness.
- Ensured compliance with ICH-GCP, FDA regulations, SOPs, and protocol requirements.
- Led site quality initiatives including CAPA development.
- Supported feasibility assessments and enrollment planning to optimize study placement.
Regional Lead Clinical Research Coordinator
GenesisCare USA
Troy, MI
02.2022 - 09.2023
- Oversaw regional operations for multiple oncology research sites, ensuring compliance and support.
- Coordinated oncology clinical trials by managing eligibility, consent, scheduling, and study visits to maintain trial integrity.
- Guided site coordinators in protocol adherence and data quality to enhance study reliability.
- Managed regulatory documentation, safety reporting, and query resolution.
- Hosted CRA monitoring visits and supported audit readiness.
- Acted as liaison between investigators, sponsors, CRAs, and regional leadership.
Study Coordinator
Hematology Oncology Associates of the Treasure Coast
Port St. Lucie, FL
08.2012 - 02.2022
- Managed Phase I-III oncology trials from start-up through close-out.
- Coordinated regulatory submissions, patient visits, data entry, and monitoring activities to ensure compliance and protocol adherence.
- Ensured inspection-ready documentation and equipment calibration records to support audit readiness and facilitate trial integrity.
Education
PCDI - Medical Office Procedures - Medical Assistant & Medical Billing
Chippewa Valley High School - Business Concentration
Skills
- Oncology Operations
- Study Start-Up
- Study Conduct
- Study Close-Out
- Regulatory Compliance
- Regulatory oversight
- Quality Management
- Quality assurance
- CAPA
- Inspection Readiness
- Feasibility
- Enrollment Strategy
- Site Performance
- Multi-Site Oversight
- Trial management
- Site coordination
- EDC
- CTMS
- ETMF
- Rave
- InForm
- Project management
- Resource management
- Budget Oversight
- Budget management
- Resource Forecasting
- Program leadership
- Leadership operations
- Operations oversight
- Cross-Functional Collaboration
- Stakeholder Collaboration
- Team collaboration
- Team supervision
- Staff Leadership
- Staff mentoring
- Training
- Training programs
- Mentorship
- Performance optimization
- Performance assessments
- Project performance metrics
- Strategic development
- Site safety
- Audit procedures
- Communication skills
- Problem resolution
- Site safety
- Team supervision
- Strategic development
- Performance assessments
Volunteer Experience
American Cancer Society
Publications
Early outcomes from lutetium Lu-177 vipivotide tetraxetan treatment in patients selected for therapy with piflufolastat F-18 PET imaging
Timeline
Clinical Research Site Director - Oncology
Profound Research
04.2024 - 11.2025
Clinical Research Site Manager
Profound Research
09.2023 - 04.2024
Regional Lead Clinical Research Coordinator
GenesisCare USA
02.2022 - 09.2023
Study Coordinator
Hematology Oncology Associates of the Treasure Coast
08.2012 - 02.2022