Key Responsibilities and Required Skills for Upper GI Research Technician
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🎯 Role Definition
The Upper GI Research Technician is a clinical research and laboratory professional who supports investigator-initiated and sponsored studies focused on the upper gastrointestinal tract (esophagus, stomach, duodenum). This role coordinates participant screening and consent, assists with endoscopic tissue acquisition, processes and documents biospecimens (fresh tissue, FFPE, blood, saliva, swabs), maintains a biobank, ensures regulatory compliance (IRB, GCP, HIPAA), and performs wet-lab assays and quality control to generate reliable data for translational research and clinical trials.
📈 Career Progression
Typical Career Path
Entry Point From:
- Clinical Research Assistant / Study Coordinator (entry-level)
- Medical Laboratory Technician or Histology Technician
- Bachelor’s graduate in Biology, Biomedical Sciences, or related field with internship experience
Advancement To:
- Senior Upper GI Research Technician / Lead Research Technician
- Clinical Research Coordinator / Clinical Trial Manager (GI studies)
- Research Laboratory Manager or Biobank Manager
Lateral Moves:
- Molecular/Genomics Lab Technician
- Histotechnologist or Immunohistochemistry Specialist
- Regulatory Affairs or Quality Assurance Associate (clinical research focus)
Core Responsibilities
Primary Functions
- Screen, recruit, and consent patients for upper GI clinical research studies — perform pre-screening chart reviews, confirm eligibility against protocol criteria, obtain informed consent using IRB-approved forms and eConsent platforms, and document consent in source documents and REDCap.
- Assist endoscopists and surgical teams during upper endoscopy/EGD procedures to coordinate research biopsies and sample collection, ensuring samples are collected per protocol timing, labeling, chain-of-custody, and biosafety requirements.
- Perform phlebotomy and peripheral blood collection for clinical trials and translational studies, including timed draws for pharmacokinetic or biomarker assessments, centrifugation, aliquoting, and cryopreservation according to SOPs.
- Process fresh tissue specimens from endoscopy and surgical biopsies: dissect, wash, divide for snap-freezing, RNAlater stabilization, culture, and fixation for FFPE; prepare matched tissue arrays and document tissue provenance.
- Manage specimen accessioning into LIMS and biobank inventory systems: generate unique IDs, print and affix barcoded labels, log collection metadata, and maintain temperature and storage logs for -80°C freezers and liquid nitrogen tanks.
- Perform nucleic acid extraction (DNA/RNA) and initial QC (Nanodrop/Qubit, RNA Integrity Number) from tissue and blood-derived samples for downstream sequencing or PCR assays, following validated protocols to minimize degradation.
- Prepare and embed tissue for histology and FFPE processing, section slides, perform H&E staining, and conduct immunohistochemistry or coordinate staining requests with pathology core labs; ensure accurate slide labeling and digital slide capture as required.
- Execute standard molecular assays including PCR, qPCR, and library preparation for sequencing under supervision; maintain reagent logs, calibration records, and follow contamination control practices.
- Maintain and troubleshoot laboratory equipment used in specimen processing and storage (centrifuges, cryogenic freezers, microtomes, biosafety cabinets); schedule preventive maintenance and coordinate service with vendors.
- Implement and adhere to GCP, HIPAA, IRB, and institutional biosafety policies for human subjects research; complete and track training including CITI, bloodborne pathogens, and lab-specific safety modules.
- Manage shipping and receiving of clinical specimens and biological materials to internal cores and external CROs/labs in compliance with IATA, FedEx Clinical Pak, and institutional SOPs, including completion of shipping manifests and dry ice handling.
- Create, update, and follow SOPs and protocol-specific sample handling instructions; propose and document process improvements to increase throughput and reduce sample loss or variability.
- Maintain study-specific regulatory binders, training logs, source documents, temperature excursion records, and adverse event reports; support monitoring visits and respond to audit queries with complete and accurate documentation.
- Enter study data into electronic data capture systems (REDCap, OnCore, eClinical) accurately and in a timely manner, resolve data queries, and perform routine data quality checks to ensure integrity of clinical and specimen metadata.
- Coordinate scheduling of participants for clinic visits, endoscopy appointments, telephone follow-up and ensure clinical care teams and research staff are aligned for protocol procedures and sample timing.
- Train, mentor, and supervise junior technicians, student interns, and visiting research fellows on biospecimen handling, lab best practices, and study-specific procedures; provide hands-on demonstrations and competency assessments.
- Participate in multidisciplinary research meetings, provide operational updates, and discuss sample availability, study timelines, and protocol feasibility with PIs, coordinators, pathologists, and core facilities.
- Contribute to study start-up activities including preparation of protocol-specific lab manuals, sample collection kits, site feasibility assessments, and budgeting of consumables and shipment costs.
- Support data analysis handoffs by preparing well-curated datasets, exporting LIMS/REDCap metadata, and annotating specimen-level variables needed by bioinformatics and biostatistics teams.
- Assist investigators in manuscript and abstract preparation by providing methods text describing sample collection, processing workflows, and QC metrics; prepare material transfer documentation as needed.
- Monitor inventory of laboratory supplies, reagents, and clinical kits; place orders, manage vendor relationships for specialty supplies (cryovials, RNA stabilization tubes), and reconcile invoices with procurement when required.
- Respond to and document deviations, protocol violations, and sample quality incidents; initiate corrective and preventive actions (CAPAs) and participate in root cause analyses to prevent recurrence.
- Ensure participant safety and comfort during research procedures by monitoring vitals when required, documenting post-procedure recovery, and escalating adverse events to the clinical team and PI per protocol.
- Support translational workflows such as primary cell culture setup from gastric/oesophageal biopsies, tissue dissociation, and maintenance under sterile conditions when protocol requires ex vivo experiments.
Secondary Functions
- Assist with grant proposals by providing operational estimates, sample throughput capabilities, and feasibility summaries for upper GI specimen collection.
- Maintain an up-to-date knowledge of best practices in tissue biobanking, molecular assay pre-analytics, and clinical trial sample management; attend workshops and trainings to implement improved methods.
- Participate in quality improvement projects to standardize tissue collection across sites, harmonize metadata fields for multi-center studies, and reduce pre-analytical variability.
- Provide back-up coverage for other lab or clinical research support roles (histology, molecular lab bench work, scheduling) during staff absences and high-volume periods.
- Support community outreach and participant recruitment initiatives by preparing informational materials, attending clinic-based recruitment events, and helping to streamline the consent experience.
Required Skills & Competencies
Hard Skills (Technical)
- Phlebotomy and venipuncture certification or demonstrated competence in timed blood collections for clinical research and biomarker studies.
- Proficient in specimen processing workflows: centrifugation, aliquoting, cryopreservation, snap-freezing, RNAlater stabilization, and FFPE handling.
- Hands-on experience with molecular biology techniques including nucleic acid extraction (DNA/RNA), PCR/qPCR, and basic library preparation steps.
- Histology and tissue processing skills: embedding, microtomy, slide preparation, H&E staining, and coordination of immunohistochemistry protocols.
- Experience with LIMS, biobank inventory systems, and barcode-based sample tracking to ensure accurate specimen provenance.
- Familiarity with electronic data capture platforms (REDCap, OnCore, eClinical) and accurate clinical research data entry practices.
- Knowledge of regulatory frameworks: IRB submissions support, GCP guidelines, HIPAA confidentiality, and human subjects protections.
- Competence in shipping biological materials following IATA and institutional biosafety/transport regulations, including dry ice logistics.
- Laboratory instrument operation and maintenance: -80°C freezers, liquid nitrogen systems, biosafety cabinets, centrifuges, Qubit/Nanodrop, and microtome.
- Document control and SOP development skills: maintain protocol-specific processing instructions, training logs, and QC records.
- Basic computer literacy and data export skills (Excel, CSV handling) to prepare sample manifests and handoffs to analytic teams.
- Experience or training in aseptic technique, contamination control, and bloodborne pathogen safety.
Soft Skills
- Strong attention to detail with meticulous documentation habits and a bias for error prevention in sample handling and data recording.
- Excellent verbal and written communication skills to interact with clinical staff, investigators, vendors, and participants.
- Time management and organizational skills to coordinate multi-participant workflows, procedure timing, and competing priorities.
- Team player mentality with the ability to work across multidisciplinary teams (clinicians, pathologists, biostatisticians, lab scientists).
- Problem-solving mindset and adaptability to modify procedures when unexpected specimen conditions or protocol amendments occur.
- Customer-service orientation toward research participants and clinical partners, maintaining professionalism and empathy.
- Integrity and discretion when handling protected health information and sensitive research data.
- Willingness to learn new technologies and adopt standardized workflows to support reproducible translational research.
- Leadership potential to train and mentor junior staff and contribute to process improvement initiatives.
- Resilience and the ability to work under time-sensitive conditions (procedural timing, clinical scheduling pressures).
Education & Experience
Educational Background
Minimum Education:
- Associate's degree in Biological Sciences, Medical Laboratory Technology, or related field with relevant laboratory/clinical experience; OR
- High school diploma with extensive hands-on clinical research or laboratory technician experience (2+ years).
Preferred Education:
- Bachelor's degree (B.S.) in Biology, Biomedical Sciences, Molecular Biology, Clinical Laboratory Science, or related discipline.
Relevant Fields of Study:
- Biology, Biomedical Sciences, Molecular Biology
- Clinical Laboratory Science, Histotechnology, Biobanking
- Public Health, Clinical Research Administration
Experience Requirements
Typical Experience Range: 1–5 years of direct experience in clinical research, laboratory specimen processing, histology, or molecular techniques; experience in an endoscopy or surgical specimen environment preferred.
Preferred:
- 2–4+ years supporting upper GI or surgical specimen collection in a clinical research setting.
- Demonstrated experience with GCP-compliant clinical trials, biobanking, LIMS, REDCap, and sample shipping logistics.
- Certifications desirable: Phlebotomy certification, CITI training, histology technician coursework, or relevant molecular assay training.