Key Responsibilities and Required Skills for Upper GI Research Specialist

🎯 Role Definition

The Upper GI Research Specialist is responsible for the operational management of clinical research studies focused on the upper gastrointestinal tract. This includes patient identification and recruitment, informed consent, scheduling and coordinating GI procedures (endoscopy/EUS/ERCP), collection and processing of biospecimens, accurate source documentation and data entry in electronic case report forms (eCRFs), monitoring readiness for sponsor/CRA visits, and ensuring regulatory and safety compliance (GCP, FDA, IRB, HIPAA). The specialist serves as the primary study contact for patients, the clinical team, investigators, sponsors, and institutional review boards.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Coordinator (CRC) within gastroenterology or surgical subspecialties
Infusion/Endoscopy nurse with research experience
Clinical data coordinator or lab technician supporting GI research

Advancement To:

Senior Clinical Research Coordinator / Lead Research Specialist — Upper GI
Clinical Research Manager or Program Manager — GI Clinical Trials
Clinical Project Manager for gastroenterology therapeutic area

Lateral Moves:

Research Regulatory Specialist (IRB/federal submissions)
Biospecimen/Clinical Lab Manager for translational GI research
Clinical Outcomes or Data Manager (EDC/OnCore focus)

Core Responsibilities

Primary Functions

Lead day‑to‑day coordination of phase I–IV and observational studies focused on upper GI conditions, ensuring enrollment targets and study timelines are met while maintaining compliance with protocol, institutional policies, GCP and applicable regulations (FDA, HIPAA).
Screen electronic health records (EHR) and endoscopy scheduling systems to identify and pre‑screen eligible patients for UGI trials; maintain and optimize pre-screening logs and recruitment pipelines to meet accrual goals.
Conduct informed consent conversations with patients and caregivers for interventional and observational upper GI studies, documenting comprehension, consent forms and consent process per IRB requirements and institutional SOPs.
Coordinate and schedule investigational procedures (upper endoscopy, EUS, ERCP), imaging, laboratory draws, and study visits; liaise with endoscopy suites, anesthesia, pathology, radiology and outpatient clinics to ensure protocol timing and sample handling.
Collect, label, process, ship and inventory biospecimens (tissue biopsies, blood, saliva, stool) according to protocol, chain of custody, and biohazard/special shipping requirements; complete specimen documentation and communication with biorepositories.
Perform accurate source documentation and timely entry of clinical data into EDC systems (REDCap, OnCore, Medidata Rave, eCRF); resolve data queries, monitor outstanding queries and reconcile source data to CRFs prior to locking.
Maintain regulatory binders and electronic regulatory files: prepare and submit IRB applications, amendments, continuing reviews and safety reports; manage informed consent form versions and investigator signature logs.
Serve as the primary contact for study sponsors, contract research organizations (CROs) and clinical research associates (CRAs) during initiation, monitoring and close‑out visits; prepare and present study documentation for monitoring review.
Review and report adverse events (AEs), serious adverse events (SAEs) and unanticipated problems within required timelines; coordinate with the principal investigator (PI) and institutional safety offices for assessments and reporting.
Ensure source documents, procedure notes, pathology reports and diagnostic results are collected and uploaded to study files; maintain study visit calendars and follow up on missed visits or deviations.
Administer study treatment per protocol when applicable (drug/dosing instructions, investigational devices, sample collection timing), including maintenance of study drug accountability logs and device inventory.
Implement recruitment strategies including community outreach, referral management with GI clinics and surgeons, patient education materials and collaboration with patient advocacy groups to increase trial awareness.
Facilitate training for clinical staff, endoscopy nurses and fellows on study protocols, informed consent processes, specimen collection procedures and protocol‑specific requirements to ensure adherence and competency.
Coordinate multi‑site communications for investigator‑initiated consortia or multi‑center trials, standardizing processes and ensuring consistent protocol conduct across locations.
Assist with budget tracking, billing compliance (clinical trial billing), study cost reconciliation and invoicing; liaise with grants and sponsored projects offices to manage timelines and financial milestones.
Participate in protocol development, feasibility assessments and site selection visits; provide operational input on visit schedules, sample logistics and patient burden to optimize study design and execution.
Manage quality assurance tasks: conduct internal audits, prepare corrective action plans for findings, and maintain SOPs and training logs for research staff.
Capture and abstract clinical outcomes and quality metrics for registries and investigator initiatives (survival, recurrence, pathology outcomes), supporting retrospective and prospective research projects.
Support investigator efforts for manuscript preparation, abstract submissions and conference presentations by extracting and validating datasets, generating tables/figures and participating in writing or review.
Maintain high standards of patient experience: provide clear instructions, empathetic communication, timely follow‑up calls and coordination of transportation or scheduling accommodations when needed.
Oversee investigational device handling, storage and sterilization logistics where applicable; coordinate device tracking, training and maintenance documentation.
Ensure data security and privacy by following HIPAA policies, secure data transfers, de‑identification procedures and controlled access to PHI and research databases.

Secondary Functions

Support ad-hoc data requests and exploratory data analysis.
Contribute to the organization's data strategy and roadmap.
Collaborate with business units to translate data needs into engineering requirements.
Participate in sprint planning and agile ceremonies within the data engineering team.
Assist in developing patient education materials, consent form language and recruitment flyers tailored to upper GI populations to improve engagement.
Maintain and update study newsletters, enrollment dashboards and progress reports for investigators and departmental leadership.
Provide mentorship to junior coordinators and research assistants; help onboard new staff and standardize training checklists.
Participate in multidisciplinary tumor boards, clinical case conferences and research meetings to ensure integration of trial options into clinical care.
Track and manage study inventory (supplies, specimen kits, lab reagents) and reorder as needed to prevent disruptions to study activities.
Support quality improvement initiatives to streamline research workflows and reduce protocol deviations.

Required Skills & Competencies

Hard Skills (Technical)

Strong knowledge of Good Clinical Practice (GCP), FDA regulations and IRB submission processes; experienced in preparing IRB applications, amendments and safety reports.
Demonstrated proficiency with Electronic Data Capture (EDC) systems such as REDCap, OnCore, Medidata Rave or equivalent; comfortable with eCRFs, data queries and source verification.
Experience with electronic health record (EHR) systems (Epic, Cerner) for patient identification, chart abstraction and scheduling coordination.
Practical knowledge of endoscopic procedures (EGD, EUS, ERCP), biopsy handling, and clinic/endoscopy workflow to align research activities with clinical care.
Biospecimen handling expertise: venipuncture/phlebotomy (where applicable), tissue/biopsy labeling, processing, cold chain management and shipping (UN3373/IATA regulations).
Clinical trial billing and budget tracking experience; familiarity with clinical trial cost centers, invoicing and sponsor budgets.
Competency in safety reporting: AE/SAE capture, coding, expedited reporting timelines and regulatory follow‑up.
Proficiency with Microsoft Office suite (Excel pivot tables, Outlook, Word) and data query/report generation; familiarity with statistical software (SAS, R) is a plus.
Experience coordinating device trials including device accountability, training and maintenance logs.
Strong documentation practices: regulatory binder management, delegation logs, training logs and SOP maintenance.

Soft Skills

Excellent verbal and written communication skills for patient interactions, consent processes, sponsor relations and scientific reporting.
High level of organization, prioritization and time management in a fast‑paced clinical trial environment with concurrent studies.
Strong attention to detail and commitment to data integrity and regulatory compliance.
Empathetic patient‑facing demeanor and cultural sensitivity when recruiting and retaining diverse patient populations.
Problem solving and critical thinking: ability to escalate, troubleshoot logistical issues and implement corrective actions.
Collaborative team player who works well with clinicians, nurses, lab staff, data managers, and external partners.
Adaptability and resilience to respond to variable clinic schedules, urgent monitoring requests and changing protocol requirements.
Leadership potential and ability to mentor junior staff and coordinate multi‑disciplinary efforts.
Project management mindset with the ability to drive studies from start‑up through close‑out.
Professionalism and confidentiality in handling protected health information (PHI) and sensitive research materials.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Life Sciences, Nursing, Public Health, Health Sciences, or related field; or equivalent combination of education and clinical research experience.

Preferred Education:

Bachelor of Science (BS) in Biology, Nursing (BSN), or Health Sciences; Master’s degree (MS, MPH) or clinical certification (CCRC, ACRP) preferred.
Advanced clinical licensure (RN, PA) or prior endoscopy nursing experience is a strong plus for procedural coordination roles.

Relevant Fields of Study:

Biology, Biomedical Sciences, Nursing
Public Health, Clinical Research, Health Administration
Oncology, Gastroenterology, Translational Research

Experience Requirements

Typical Experience Range: 2–5+ years of clinical research coordination experience, with at least 1–2 years working in gastroenterology, endoscopy or oncology research preferred.

Preferred:

Prior experience managing investigator‑initiated or sponsor‑driven upper GI clinical trials.
Demonstrated track record of meeting enrollment targets and maintaining high data quality in an academic medical center or industry site.
Experience with multi‑site trials, CRO/Sponsor interactions and CRA monitoring visits.
Certifications such as CCRC, SOCRA, ACRP or human subjects research training (CITI) are preferred.