Key Responsibilities and Required Skills for Upper GI Research Assistant

🎯 Role Definition

The Upper GI Research Assistant supports clinical and translational research focused on the upper gastrointestinal tract (esophagus, stomach, duodenum). This role coordinates patient-facing activities, collects and processes clinical specimens, maintains trial documentation, and works closely with investigators, study coordinators, endoscopy nurses, and regulatory teams to ensure high-quality, compliant execution of observational studies and interventional clinical trials in gastroenterology and endoscopy. Ideal candidates have hands-on clinical exposure in endoscopy settings, strong data management skills (REDCap/EDC), and demonstrated familiarity with IRB processes and Good Clinical Practice (GCP).

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Intern or Volunteer supporting GI studies
Medical Laboratory Technician or Phlebotomy Tech with interest in clinical research
Recent graduates with B.S. in Biology, Neuroscience, Public Health, or Nursing

Advancement To:

Senior Research Assistant / Lead Research Assistant (Upper GI focus)
Clinical Research Coordinator (CRC) or Clinical Trials Coordinator
Study Manager or Clinical Project Coordinator for gastroenterology studies

Lateral Moves:

Data Coordinator / Clinical Data Manager (EDC/REDCap specialist)
Patient Recruitment Specialist or Clinical Research Educator

Core Responsibilities

Primary Functions

Coordinate and execute day-to-day activities for upper GI clinical research studies, including scheduling patient visits, coordinating endoscopy appointments, and ensuring protocol adherence across outpatient and inpatient settings.
Obtain informed consent from study participants in a clear, ethical manner, documenting the consent process thoroughly and answering participant questions about study procedures, risks, and follow-up requirements.
Screen electronic health records (EHR) and clinic schedules to identify potential study participants using inclusion/exclusion criteria, and coordinate with treating physicians and endoscopy teams to approach eligible patients.
Collect clinical data at baseline and follow-up visits through structured interviews, chart review, validated questionnaires (e.g., symptom scores), and standardized case report forms, ensuring completeness and accuracy of all data fields.
Assist with or perform specimen collection (blood, tissue biopsies, brushings, saliva, stool) in compliance with protocol procedures and biosafety regulations, label specimens accurately, and coordinate timely transport to the laboratory for processing and storage.
Perform and document standardized clinical assessments related to upper GI function, including symptom scoring, dietary and medication reconciliation, and collection of procedural details from endoscopy reports.
Maintain accurate, audit-ready study files including regulatory binders, delegation logs, source documents, consent forms, and investigator communications; ensure all documentation meets institutional and sponsor requirements.
Enter and query clinical trial data in electronic data capture systems (REDCap, Medidata Rave, OpenClinica) promptly, reconcile discrepancies, and coordinate data queries with monitors and data management teams.
Prepare and ship biological specimens per protocol and federal/state regulations, complete chain-of-custody documentation, and maintain specimen inventory in laboratory information systems or sample tracking logs.
Support protocol development and amendments by drafting standard operating procedures (SOPs), visit checklists, case report form (CRF) instructions, and data collection templates tailored to upper GI endpoints.
Collaborate directly with endoscopy nursing staff and procedural teams to align research procedures with clinical workflows, minimize patient burden, and ensure safe conduct of study-related interventions during endoscopic procedures.
Assist investigators with screening logs, enrollment tracking, and accrual reporting; proactively identify barriers to recruitment and propose mitigation strategies (e.g., optimized screening scripts, targeted outreach).
Monitor participant adverse events and concomitant medication changes, document clinical outcomes in source documents, and notify the principal investigator and safety team according to protocol timelines and institutional policies.
Coordinate on-site and remote monitoring visits by sponsors and CROs, provide requested source documentation, and implement corrective actions to resolve monitor findings and audit observations.
Maintain up-to-date training records and certifications (GCP, HIPAA, biosafety, phlebotomy) for all delegated staff and ensure alignment of training with delegation of authority logs.
Facilitate patient follow-up including appointment reminders, travel coordination, compensation processing, and troubleshooting of participant barriers to retention to maximize study completion rates.
Conduct quality control reviews of collected data and specimens, run basic descriptive QC checks (range checks, missing data reports), and escalate complex issues to the clinical data manager or PI for resolution.
Support multi-site or collaborative upper GI research efforts by coordinating inter-institutional specimen transfers, harmonizing SOPs, and participating in investigator meetings or working groups as required.
Prepare study-related materials for IRB submissions and continuing review (protocol summaries, consent form changes, recruitment materials), and maintain clear communication with the IRB office regarding reportable events and amendments.
Maintain inventory of research supplies and study-specific equipment, place timely orders, and manage budgets for consumables and shipping to ensure uninterrupted study operations.
Educate clinic staff and new research team members on study-specific procedures, eligibility criteria, and participant interaction best practices to ensure consistent study conduct and high-quality data collection.

Secondary Functions

Support the development and delivery of participant-facing educational materials and recruitment advertisements optimized for clinic waiting rooms and patient portals.
Assist with exploratory data pulls and summary tables for investigator meetings, slide decks, and grant progress reports in collaboration with data analysts.
Participate in quality improvement projects to streamline endoscopy-based research workflows and reduce variability in sample collection and processing.
Help maintain and update project management trackers, accrual dashboards, and recruitment heatmaps for leadership review and operational planning.
Represent the research team at departmental meetings and assist with onboarding of new investigators and collaborators to research protocols and site capabilities.
Provide cross-coverage for other GI research studies (colorectal, hepatology) when needed to maintain continuity of research operations during peak periods or staff absences.

Required Skills & Competencies

Hard Skills (Technical)

Proven experience with clinical research operations in gastroenterology, endoscopy, or related disciplines, including patient-facing and procedural coordination.
Strong working knowledge of Good Clinical Practice (GCP) guidelines and experience applying GCP principles to day-to-day study activities.
Experience preparing IRB submissions, amendments, continuing reviews, and regulatory documentation for human subjects research.
Proficiency in electronic data capture systems such as REDCap, Medidata Rave, OpenClinica, or similar EDC platforms, including data entry, query resolution, and export routines.
Experience working with electronic health records (Epic, Cerner, or similar) for screening, source documentation, and medical record abstraction.
Hands-on experience with specimen handling and processing (phlebotomy, biospecimen labeling, aliquoting, cold chain management) and maintaining chain-of-custody.
Familiarity with adverse event reporting, SAE documentation, and safety reporting workflows to sponsors and IRBs.
Competence with Microsoft Office suite (Excel for tracking, Word for reports, PowerPoint for presentations) and basic data summarization skills.
Prior exposure to clinical trial monitoring and audit processes, including responding to sponsor/CRO queries and implementing corrective actions.
Knowledge of HIPAA privacy requirements and experience maintaining participant confidentiality and secure study records.
Basic statistical literacy and the ability to run descriptive summaries or prepare datasets for analysts using tools like Excel, SPSS, R, or SAS is advantageous.
Experience maintaining regulatory binders, delegation logs, and training matrices to ensure audit readiness.

Soft Skills

Excellent interpersonal and verbal communication skills for interacting with patients, investigators, and clinical teams in a respectful and clear manner.
High attention to detail and accuracy in data collection, specimen management, and documentation to support reproducible research.
Strong organizational skills and the ability to manage competing priorities across multiple studies and fast-paced clinical environments.
Problem-solving aptitude with a proactive mindset to identify barriers to enrollment, data quality issues, or logistic challenges and propose practical solutions.
Empathy and professionalism when working with patients who may be anxious about procedures, ensuring informed decision-making and compassionate care.
Team-player mentality with demonstrated ability to collaborate across multidisciplinary teams including clinicians, nurses, lab staff, and data managers.
Flexibility and adaptability to cover research activities across clinic, endoscopy suite, and occasional evening/weekend visits as study protocols require.
Time management skills and ability to meet deadlines for IRB submissions, monitoring requests, and sample shipment windows.
Confidentiality and ethical judgment in handling sensitive patient information and study results.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree (B.S. or B.A.) in Biology, Nursing, Public Health, Biomedical Sciences, or a related health/science discipline; or equivalent clinical experience.

Preferred Education:

Master's degree (MS, MPH) in a related field, or a Bachelor’s degree plus certification in clinical research (SOCRA, ACRP, or CCRC) or nursing qualification (RN) with research experience.

Relevant Fields of Study:

Biology, Biomedical Sciences, or Physiology
Nursing or Clinical Nursing
Public Health or Epidemiology
Clinical Research, Health Sciences, or Medical Laboratory Technology

Experience Requirements

Typical Experience Range:

1–4 years of clinical research or relevant clinical experience, preferably including work in gastroenterology, endoscopy, or procedural clinic settings.

Preferred:

2+ years supporting clinical trials or observational studies in GI or surgical/endoscopy environments, with demonstrated skills in participant recruitment, REDCap/EDC use, specimen handling, and regulatory compliance (IRB, GCP, HIPAA).