Biologistics Operations Manager

Position Title: Biologistics Operations Manager

Reports To: President - Pattern.org

Organization: Rare Cancer Research Foundation

Location: On site at RCRF headquarters: 703 Foster St, Durham, NC 27701

Hours: Flexible but need ability to work non-standard hours to manage shipment requirements and client requests. At times may require overnight travel.

Position Summary

The Biologistics Operations Manager is responsible for the strategic oversight and day-to-day execution of all biospecimen logistics operations supporting the Rare Cancer Research Foundation's programs. This role ensures the seamless collection, packaging, transportation, tracking, storage, and distribution of patient tissue and fluid samples from hospitals and clinics to and from biobanking and research facilities.

The Biologistics Manager serves as the operational liaison between clinical sites, shipping vendors, biobank partners, external research partners and internal teams to ensure the integrity, compliance, and timely movement and tracking of biospecimens.

Key Responsibilities

Biospecimen Collection Program Management

• Implement and oversee tissue and fluid collections across participating hospitals and clinical sites.
• Maintain standardized collection protocols and operating procedures and recommend to leadership any changes or improvements needed.
• Coordinate with hospital pathology, surgery, radiology, and laboratory personnel to facilitate specimen collection for select patients. Manage any institutional issues that may arise.
• Oversee staff that coordinate with hospital pathology, surgery, radiology, and laboratory personnel to facilitate general research specimen collection. Manage any institutional issues that may arise.
• Ensure collection activities comply with regulatory, ethical, and RCRF requirements.

Kit Development and Distribution

• Manage the creation, assembly, quality control, and inventory management of tissue and fluid collection kits.
• Ensure kits contain all required collection materials, labeling components, shipping supplies, and instructions to meet regulatory and RCRF requirements.
• Manage forecasting and replenishment of kit inventory.
• Coordinate nationwide distribution of kits to partner hospitals and/or clinicians.

Shipping and Logistics Operations

• Manage overnight shipping programs for outbound collection kits and inbound biospecimens. Coordinate closely with administrative support personnel.
• Establish and maintain relationships with courier and shipping vendors.
• Monitor time-sensitive shipments to ensure specimen viability and any chain-of-custody requirements.
• Work with administrative support personnel to resolve shipping delays, temperature excursions, and logistical issues in real time.

Clinical Site and Hospital Relations

• Conduct onboarding, training, and ongoing support for specified clinical partners.
• Oversee clinical on-site staff and patient navigation personnel to ensure collection effectiveness, efficiencies and strong partner relationships.

Biobank Operations and Sample Tracking

• Oversee end-to-end tracking of tissue and fluid samples from collection through storage and distribution.
• Maintain accurate documentation and inventory records.
• Coordinate sample intake, processing, storage, and retrieval activities with biobank partner(s).
• Ensure complete visibility of specimen movement into and out of the biobank.

Data Management and Quality Assurance

• Utilize existing systems for specimen tracking, inventory management, and logistics reporting.
• Monitor key performance indicators including collection success rates, shipment timelines, kit utilization, and specimen quality.
• Conduct audits to ensure adherence to SOPs and quality standards.
• Develop corrective action plans when operational issues are identified.
• Collaborate with RCRF’s Data Platform team to ensure seamless data and tissue connection.

Regulatory Compliance

• Ensure compliance with applicable regulations governing human biospecimens, including HIPAA, IRB requirements, and applicable federal and state regulations.
• Maintain documentation supporting specimen handling, transportation, and storage activities.
• Collaborate with leadership on any necessary changes to biospecimen governance documents.

Leadership and Strategic Planning

• Develop and execute biologistics strategies that support organizational growth and research objectives.
• Manage budgets related to kit production, shipping, biobanking, and logistics operations.
• Lead and mentor designated biologistics and operations personnel.
• Identify opportunities to improve operational efficiency, scalability, and participant experience.

Required Qualifications

• Bachelor's degree in Biological Sciences, Life Sciences, Healthcare Administration, or related field.
• Experience working with tight deadlines and ability to have a flexible schedule.
• Strong project management and operational leadership skills.
• Excellent communication and relationship-management abilities.
• Compassionate, emotionally resilient and highly adaptable personality 
• Strong attention to detail.

Preferred Qualifications

• Experience supporting oncology, rare disease, or translational research programs.
• Experience working with hospital pathology departments, clinical laboratories, research institutions and/or oncology patients
• Experience implementing laboratory information management systems (LIMS) or biospecimen tracking platforms.
• MPH degree.

Key Competencies

• Operational excellence
• Leadership & Strong Communication skills
• Regulatory compliance
• Relationship management
• Process improvement
• Data-driven decision making
• Strategic planning
• Team leadership
• Problem solving under time-sensitive conditions
• Empathy for cancer patients;ability to work with diverse personalities and expectations

Success Measures

• Timely creation & delivery of collection kits to sites
• Successful receipt and processing of biospecimens
• Sample integrity and quality metrics
• Accuracy of inventory and shipping records
• Partner site satisfaction and engagement
• Compliance with regulatory and operational standards
• Operational efficiency and cost management

Mission Impact: This role directly enables rare cancer research by ensuring that high-quality patient tissue and fluid samples are collected, preserved, tracked, and made available to researchers seeking new discoveries and treatments for cancers.

To apply:

Send cover letter and CV/Resume to hiring@rcrf.org. Will only consider candidates who reside in the Durham/Chapel Hill/Raleigh area.