BioSpecimen Research Coordinator

Company Description

BioCytics is a biotechnology company developing a personalized immuno-oncology platform focused on novel cellular therapies for cancer. Incubated within the Carolina BioOncology Institute, a leading independent Phase I clinical trial site, BioCytics benefits from proximity to clinical research while operating independently. The company offers contract R&D services, wet lab space, and conducts translational research supported by an IRB-approved biospecimen collection study (BioCytics 0001; NCT00571389). Founded in 2005 by Dr. John Powderly, a board-certified oncologist and Certified Physician Investigator, BioCytics is advancing the future of precision medicine through research, collaboration, and innovation.

Position Title: BioSpecimen Research Coordinator

Schedule: Onsite, Full-Time; Monday–Thursday 8 am–5 pm, Friday 8 am–12 pm

Role Description

The BioSpecimen Research Coordinator is responsible for the sourcing, collection, documentation, and coordination of biospecimens across a range of clinical research studies. This role supports both internal and external investigator-initiated and sponsor-driven trials, ensuring compliance with regulatory and ethical standards. The coordinator will collaborate across multidisciplinary teams and contribute to the development and implementation of biospecimen-related quality and operational processes.

Duties/Responsibilities

• Conduct all biospecimen-related activities in accordance with Federal Drug Administration (FDA) regulations, GCP (Good Clinical Practice), IRB (Institutional Review Board) requirements, and International Council for Harmonization (ICH) guidelines.
• Adhere to applicable FDA standards for Good Manufacturing Process (GMP), Good Laboratory Practices (GLP), Good Tissue Practices (GTP), Good Documentation Practices (GDP), Good Clinical Practices (GCP), as well as International Society of Cellular Therapy (ISCT), Foundation for the Accreditation of Cellular Therapy (FACT), and Association for the Advancement of Blood & Biotherapies (AABB) guidelines for cellular therapy, blood, and tissue products.
• Recruit, consent, and screen study participants per protocol-defined inclusion/exclusion criteria; ensure accurate enrollment tracking and maintain strict patient confidentiality.
• Schedule and oversee patient visits, sample collection, and study procedures to ensure protocol compliance and data integrity.
• Collect, label, store, and ship biospecimens in accordance with protocol, SOPs, and regulatory standards.
• Coordinate apheresis procedures and hospital biospecimen pickups; manage transportation and chain-of-custody documentation.
• Prepare and maintain study documents including informed consent forms (ICFs), case report forms (CRFs), source documentation, regulatory binders, collection logs, and certificates of analysis (CoAs).
• Enter and manage source data in electronic data capture (EDC) systems; resolve data queries and ensure timely, accurate reporting.
• Report and document adverse events (AEs) and serious adverse events (SAEs) per protocol and regulatory requirements.
• Ensure biospecimen traceability using inventory tools; support the capacity of the live biobank, including accurate clinical and scientific metadata of donors and usage tracking.
• Assist with internal and external audits or inspections by ensuring documentation and procedures are audit-ready and compliant.
• Develop, revise, and follow SOPs related to biospecimen handling, regulatory processes, and clinical procedures.
• Able to independently and confidently train staff or cross-functional team members on study protocols, regulatory compliance, biospecimen handling, and documentation practices.
• Support and collaborate with multidisciplinary teams, including clinical, lab, regulatory, and quality, as well as external clients, sponsors, and academic partners.
• Build and maintain professional relationships with sponsors and clients; assist in identifying and supporting new biospecimen sourcing or partnership opportunities.
• Proficiency with Microsoft Office 365 tools, such as Word, Excel, Outlook, OneNote, SharePoint, and Teams.

Required Skills/Abilities:

• Organization & Time Management: Effectively prioritizes tasks, manages time efficiently, and meets deadlines in a dynamic clinical environment.
• Critical Thinking & Problem Solving: Identifies issues, analyzes information, and develops appropriate solutions in a timely manner.
• Attention to Detail & Quality: Demonstrates accuracy, thoroughness, and a strong commitment to regulatory and data integrity.
• Teamwork & Collaboration: Works effectively across interdisciplinary teams and fosters a positive, team-oriented culture.
• Adaptability & Flexibility: Responds well to change, shifting priorities, and unexpected challenges; contributes to ongoing process improvement.
• Dependability: Maintains reliable attendance and punctuality; completes assigned tasks or communicates proactively when adjustments are needed.
• Independence & Initiative: Works effectively with minimal supervision; takes ownership of responsibilities, anticipates needs, and makes proactive, informed decisions aligned with project and organizational goals.
• Service Orientation: Aligns with the organization’s values and responds promptly to the needs of patients, clients, and sponsors.
• Communication & Interpersonal Skills: Communicates clearly and professionally with patients, colleagues, and external stakeholders.
• Technical Proficiency: Comfortable using Microsoft Office 365 tools.
• Compliance & Safety Awareness: Adheres to safety, security, and ethical guidelines in all research and clinical procedures.

Education and Experience:

• Bachelor’s degree in a science, healthcare, or research-related field preferred.
• Clinical and/or research experience strongly preferred.
• Experience with Power BI, Laboratory Information Management System (LIMS) platform, and Electronic Data Capture (EDC) systems is preferred.
• Professional research certification (e.g., ACRP, SOCRA) is preferred, but not required.