Clinical Research Associate (CRA) – Remote (U.S.)
Company Description
iProcess Global Research Inc. is a leading global provider of biospecimens, regulatory support, project management, and lab services, supporting research labs, manufacturers, and companies in the diagnostic, life science, medical device, and pharmaceutical industries.
With a vast network spanning hundreds of sites across North America, Europe, Africa, South America, and Asia, iProcess enables innovative scientific advancements by providing high-quality human biospecimens and coordinated research services. As the trusted procurement and operations partner for numerous organizations, we are dedicated to enabling meaningful research and discovery worldwide.
Role Overview
We are seeking a Clinical Research Associate (CRA) with a strong background in clinical research coordination and project management, ideally with exposure to multiple therapeutic areas and study phases.
This role combines elements of traditional clinical research coordination with broader project oversight—supporting both clinical and biospecimen-based studies. You will coordinate multiple concurrent projects—from startup through close-out—collaborating closely with internal teams, clinical sites, labs, and clients to ensure projects are executed on time, within scope, and with high quality.
We welcome applicants currently working as Clinical Research Coordinators (CRCs) or similar roles who are ready to step into a more project-focused, sponsor/vendor-side position. Prior “CRA” title is not required.
This is a remote position based in the U.S.
Key Responsibilities
Study & Project Coordination
- Manage multiple biospecimen-focused clinical research projects from feasibility/start-up through close-out, including both interventional and observational study support.
- Coordinate with clinical sites, hospitals, and laboratories to establish workflows for sample collection, processing, storage, and shipment in alignment with study protocols and regulatory requirements.
- Lead or contribute to protocol development, study design input, and supporting document creation (e.g., ICFs, lab manuals, collection instructions, project plans).
- Oversee timelines and deliverables for biospecimen acquisition, data collection, and documentation, ensuring milestones are achieved and risks mitigated.
- Track site performance, enrollment progress, and sample logistics while proactively identifying and resolving delays or operational challenges.
Operational Oversight
- Develop and maintain detailed project trackers, study timelines, and operational plans specific to biospecimen trials.
- Ensure site and lab teams clearly understand biospecimen handling SOPs, study objectives, and collection requirements.
- Support the preparation, review, and maintenance of project documentation such as protocols, lab manuals, sample handling guides, shipment instructions, and regulatory binders.
Site & Client Communication
- Serve as a key operational contact for clinical sites, laboratories, couriers, and clients on assigned biospecimen studies.
- Support site start-up, training, and onboarding related to sample collection procedures, documentation, and data entry.
- Facilitate regular project update meetings, action logs, and communications to ensure all stakeholders remain aligned and informed.
Quality, Compliance & Documentation
- Ensure studies are conducted in accordance with protocols, IRB/ethics requirements, and applicable regulations (e.g., GCP, HIPAA, IATA).
- Maintain accurate, complete, and timely project documentation including protocol versions, sample manifests, collection logs, and reconciliation reports.
- Support quality checks and reconciliation of data and samples between sites, labs, couriers, and clients.
Reporting & Cross-functional Collaboration
- Prepare status and tracking reports summarizing biospecimen collections, shipments, and project progress for internal and client stakeholders.
- Collaborate with operations, data management, and regulatory teams to ensure biospecimen data accuracy and compliance.
- Contribute to process improvement initiatives and best practices for biospecimen trial operations, documentation, and logistics.
Required Qualifications
- Bachelor’s degree in life sciences, health sciences, or a related field.
- 3 to 4+ years of experience in clinical research, ideally as a Clinical Research Coordinator (CRC) or similar study coordination role.
- Familiarity with clinical protocols, informed consent, and basic regulatory/IRB processes.
- Strong organizational and project coordination skills with the ability to manage multiple priorities.
- Excellent communication and documentation skills.
- Proficiency with common project tools (e.g., Excel, Word, PowerPoint, shared drives).
- Ability to work independently in a remote, cross-functional environment.
Preferred Qualifications (Nice to Have)
- Prior experience with biospecimen procurement, biobanks, central labs, or reference labs.
- Experience coordinating multi-site studies or working with CROs, sponsors, or vendors.
- Familiarity with GCP/ICH guidelines, HIPAA, and basic data privacy principles.
- Experience using CTMS, EDC, LIMS, or other research/lab management systems.
- Background in oncology, infectious disease, or diagnostic/assay development projects.
What We Offer
- Fully remote role with a global, mission-driven team.
- Opportunity to work on diverse, real-world research projects across multiple therapeutic areas.
- Exposure to both biospecimen operations and lab services, with room to grow into more senior project or operations roles.
- Collaborative culture where ideas and initiative are valued.
If you have a solid foundation as a Clinical Research Coordinator or similar, are comfortable working with biospecimens and labs, and enjoy keeping complex projects organized and moving forward, we would love to hear from you.