Key Responsibilities and Required Skills for Upper GI Research Coordinator

🎯 Role Definition

The Upper GI Research Coordinator is a clinical research professional who manages the day-to-day conduct of interventional and observational trials focused on the upper gastrointestinal tract (esophageal, gastric, gastroesophageal junction). This role ensures protocol adherence, subject safety, high-quality data collection, and regulatory compliance across screening, enrollment, treatment, follow-up, and biospecimen workflows. The Coordinator serves as the primary liaison between principal investigators, study sponsors/CROs, clinical teams (endoscopy, pathology, radiology, pharmacy), and institutional review boards (IRBs).

Keywords: Upper GI Research Coordinator, clinical research coordinator, esophageal cancer trial, gastric cancer trial, endoscopy research, clinical trials management, GCP, IRB submissions, biospecimen collection.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Assistant / Technician
Registered Nurse (RN) or Licensed Practical Nurse (LPN) with research experience
Medical Assistant or Endoscopy Technician with clinical trial exposure

Advancement To:

Senior Clinical Research Coordinator / Lead CRC
Clinical Trials Manager / Research Manager
Study Start-up Manager or Clinical Research Operations Manager
Clinical Research Program Director or Clinical Research Nurse Specialist

Lateral Moves:

Regulatory Affairs Specialist / IRB Coordinator
Data Manager / Clinical Data Coordinator
Clinical Research Quality Assurance / Auditor

Core Responsibilities

Primary Functions

Lead participant recruitment and screening for upper GI clinical trials by conducting chart reviews, prescreening via EHR, coordinating with referring gastroenterologists and surgeons, and implementing targeted recruitment strategies to meet enrollment targets.
Obtain and document informed consent per protocol and institutional policy, clearly explaining study procedures, risks, benefits, and alternatives to participants and answering questions in an empathetic, health-literate manner.
Coordinate and schedule study-related procedures including endoscopies, biopsies, imaging (CT/PET/MRI), pathology specimen collection, and clinic visits to align with protocol windows and clinical team availability.
Oversee specimen management for tissue, blood, and other biospecimens: label, process, store, log, and prepare shipments under appropriate biosafety and chain-of-custody procedures; liaise with biobank and pathology for sample accessioning.
Maintain meticulous source documentation and enter accurate, query-free data into the study EDC/CRF (e.g., Medidata Rave, REDCap, eClinicalWorks), ensuring timely query resolution and audit readiness.
Monitor, identify, and report adverse events (AEs), serious adverse events (SAEs), and unanticipated problems to the PI, sponsor, and IRB within required timelines, compiling source documentation and follow-up reports as needed.
Manage protocol deviations, violations, and noncompliance events: investigate causes, draft corrective and preventive actions (CAPAs), and submit required notifications to regulatory bodies and sponsors.
Serve as primary contact for sponsor and CRO monitoring visits, preparing regulatory binders, facilitating monitor access to source documents, responding to monitoring findings, and implementing action plans.
Support study start-up activities including feasibility assessments, site qualification visits, budget negotiations, contract routing, and activation checklists to achieve timely site initiation.
Coordinate pharmacy interactions for investigational product accountability, randomization processes, drug storage, dosing logs, cold-chain requirements, and reconciliation of dispensed vs. returned investigational materials.
Collaborate with multidisciplinary clinical teams (GI oncology, surgical oncology, pathology, radiology, anesthesia) to ensure study procedures are integrated safely into routine care and to optimize patient flow for endoscopic interventions.
Execute longitudinal participant follow-up, survivorship assessments, and disease progression documentation, including remote/phone follow-ups, PRO collection, and maintaining up-to-date survival status for long-term endpoints.
Prepare, maintain, and update regulatory documents: IRB submissions and renewals, protocol amendments, consent form revisions, delegation logs, CVs, medical licenses, and training records to ensure inspection-ready regulatory files.
Implement quality control processes to ensure CRF completeness, source-to-CRF verification, and data integrity checks prior to database lock; escalate data discrepancies and collaborate with data management to close queries.
Train and supervise junior research staff, study-specific coordinators, and cross-cover personnel on protocol procedures, GCP, blood/tissue handling, and study-specific SOPs to ensure consistent quality across shifts.
Execute screening logs, enrollment tracking, milestone reports, and recruitment pipeline analyses; present enrollment status and operational metrics at investigator meetings and departmental research reviews.
Manage study budgets, track study-related expenses, process participant stipends and reimbursements, and collaborate with billing compliance to separate study-related care from standard of care for accurate invoicing.
Support site-initiated and investigator-initiated trials by drafting study documents, coordinating pilot procedures, and assisting with protocol development feedback grounded in site logistics and patient population characteristics.
Facilitate patient education and retention activities, including appointment reminders, travel coordination, translation services when needed, and addressing social determinants that may affect adherence to study visits.
Participate in safety data reviews, tumor board discussions, and case reviews to ensure timely communication of clinically relevant findings to investigators and treating clinicians.
Coordinate imaging and pathology review processes (central reads, blinded assessments), compile de-identified imaging stacks and pathology slides, and prepare materials for adjudication committees.
Ensure compliance with HIPAA and institutional privacy policies when collecting, storing, and transmitting protected health information (PHI), including proper use of de-identification and data transfer agreements.
Contribute to manuscript preparation, abstract development, and conference presentations by providing accurate dataset summaries, timelines, and operational insights to support publications and scientific dissemination.
Maintain and update SOPs and site-specific procedures for Upper GI clinical trials based on sponsor requirements, regulatory guidance, and lessons learned from audits or inspections.
Coordinate emergency coverage and escalation pathways for urgent study-related events such as SAE management, unblinding requests, or device malfunctions during endoscopic procedures.

Secondary Functions

Support recruitment campaign development, community outreach, and physician engagement to expand referral networks for upper GI studies.
Participate in departmental and institutional quality improvement initiatives related to clinical research operations, including process mapping and workflow optimization.
Assist with training materials and onboarding modules for new hires and cross-functional partners to standardize study conduct and compliance.
Contribute to electronic health record (EHR) build requests, order sets, and clinical decision support tools that streamline study procedures in the clinical workflow.
Provide back-up coverage for other clinical research studies within the GI or oncology portfolio when needed to maintain continuity of patient care and data capture.

Required Skills & Competencies

Hard Skills (Technical)

In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and IRB submission processes relevant to clinical trials.
Proven experience with electronic data capture systems (EDC) such as Medidata Rave, REDCap, Castor, or Oracle Clinical and strong CRF completion skills.
Proficient use of electronic health records (EHR) systems (Epic, Cerner, or equivalent) for chart reviews, scheduling, and order entry related to study visits.
Demonstrated experience in biospecimen collection, processing, labeling, storage (LN2, -80C), and shipment following chain-of-custody and biosafety protocols.
Competency in adverse event and SAE assessment, medical documentation, and timely regulatory reporting in accordance with sponsor and institutional timelines.
Experience coordinating procedures in the endoscopy suite (EGD, EUS) and interfacing with endoscopy schedulers, anesthesia, and nursing staff.
Familiarity with oncology-specific documentation: tumor staging, RECIST criteria, response assessments, and survival endpoint capture.
Experience with pharmacy coordination for investigational product management, randomization systems, and blinding/unblinding procedures.
Strong document control skills: maintaining regulatory binders, delegation logs, training records, and version control for consent forms and protocols.
Competence in Microsoft Office suite (Excel for tracking logs and pivot reports, Word for study documents, PowerPoint for presentations).
Basic statistical literacy and familiarity with clinical research metrics: enrollment rates, screen fail rates, retention, and database lock procedures.
Experience supporting monitoring, audits, and inspections including preparation of monitoring files and executing corrective action plans.

Soft Skills

Excellent patient-facing communication and bedside manner: able to explain complex clinical trial information clearly and empathetically to diverse populations.
Exceptional organizational skills with the ability to manage multiple studies, competing priorities, and frequently changing timelines.
Strong critical thinking and problem-solving skills to troubleshoot operational challenges and propose scalable process improvements.
Collaborative team player who builds strong relationships with investigators, clinical staff, sponsors, and cross-functional research partners.
High attention to detail and reliability in maintaining accurate, regulatory-compliant documentation and data.
Flexibility and adaptability to respond to after-hours events, urgent safety issues, and evolving trial requirements.
Cultural competency and sensitivity to patient needs, including working effectively with interpreters and diverse patient populations.
Time management and prioritization skills to meet enrollment targets, data deadlines, and reporting milestones.
Professionalism and integrity with strict adherence to patient confidentiality and ethical research conduct.
Leadership and mentorship skills to train, guide, and develop junior research staff while maintaining quality standards.

Education & Experience

Educational Background

Minimum Education:

Associate degree in health sciences, biological sciences, nursing, or related field OR high school diploma with strong clinical research experience and certifications.

Preferred Education:

Bachelor's degree in Nursing, Biology, Public Health, Clinical Research, or related field.
Registered Nurse (RN) preferred for complex interventional protocols requiring clinical assessments.
Advanced degrees (MS, MPH) or clinical research certifications (CCRC, ACRP, SoCRA) are advantageous.

Relevant Fields of Study:

Nursing (BSN/RN)
Clinical Research/Research Administration
Biology, Biomedical Sciences, or Life Sciences
Public Health or Health Administration
Oncology or Gastroenterology-related specialties

Experience Requirements

Typical Experience Range:

2–5 years of clinical research coordination experience, ideally with a minimum of 1–2 years on oncology or upper GI protocols.

Preferred:

3+ years coordinating interventional trials in gastroenterology, oncology, or surgical oncology with documented enrollment success.
Prior experience in endoscopy suite workflows, biospecimen handling, and working with multidisciplinary tumor boards.
Demonstrated history of successful sponsor/CRO interactions, monitoring visit readiness, and audit/inspection support.
Certifications such as CCRC or completion of Good Clinical Practice training preferred.