Key Responsibilities and Required Skills for Upper GI Research Analyst

🎯 Role Definition

This role requires an experienced and detail-oriented Upper GI Research Analyst to drive clinical and translational research projects focused on the upper gastrointestinal tract (esophagus, stomach, proximal small bowel). The ideal candidate partners with clinicians, biostatisticians, pathology, and regulatory teams to design studies, manage data and samples, perform rigorous analyses, and communicate findings to clinical and scientific stakeholders. This role emphasizes protocol development, patient and sample tracking, regulatory compliance (IRB/GCP/HIPAA), and production of high-quality deliverables such as abstracts, manuscripts, and grant materials. Strong technical capability with clinical databases and statistical tools, combined with domain knowledge in endoscopy, GI oncology, and surgical outcomes, is essential.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Coordinator with GI or oncology experience
Data Analyst or Biostatistician supporting clinical trials
Laboratory Research Technician in GI or pathology groups

Advancement To:

Senior Upper GI Research Analyst / Research Scientist
Clinical Research Manager or Study Lead (Upper GI programs)
Clinical Data Scientist / Biostatistics Associate

Lateral Moves:

Translational Research Associate (biomarkers / pathology)
Clinical Trials Project Manager (CRO or academic center)

Core Responsibilities

Primary Functions

Lead the design, implementation, and operational execution of prospective and retrospective Upper GI clinical research projects, including writing and refining protocols, developing study-specific procedures, and coordinating multi-disciplinary input to ensure scientific rigor and feasibility.
Develop comprehensive statistical analysis plans in collaboration with biostatisticians; execute and interpret survival analyses, multivariable models, time-to-event analyses, and subgroup evaluations tailored to esophageal and gastric disease outcomes using R, SAS, or Python.
Oversee patient recruitment and enrollment workflows for upper GI studies by developing screening strategies, liaising with clinical teams and endoscopy units, tracking accrual metrics, and implementing corrective actions to meet enrollment targets.
Manage clinical data capture and integrity across EDC platforms (e.g., REDCap, Medidata Rave, Oracle Clinical), including CRF design, data dictionary maintenance, source-data verification coordination, and resolution of data queries with site investigators.
Maintain and curate longitudinal Upper GI registries and research databases to facilitate real-world evidence studies and secondary analyses, ensuring consistent variable definitions, ontology mapping (ICD-10/CPT), and high data quality.
Coordinate biospecimen collection, processing, storage, and shipping for tissue, blood, and endoscopy-derived samples; create tracking logs and SOPs to ensure chain-of-custody and compliance with biobank standards.
Prepare and submit regulatory documents for IRB review, amendments, and continuing reviews; ensure all study activities comply with GCP, ICH guidelines, and institutional policies protecting human subjects.
Monitor safety events and adverse event reporting related to investigational procedures or treatments, collaborating with clinical investigators to prepare timely safety reports and event adjudication documentation.
Conduct systematic literature reviews and evidence syntheses to inform study hypotheses, background sections for grants, and protocol rationale; translate literature findings into testable aims and endpoints specific to upper GI disease mechanisms and treatments.
Produce high-quality scientific deliverables including tables, figures, abstracts, posters, and manuscripts; manage author lists, coordinate writing timelines, and respond to peer review comments for publication submissions.
Design and implement data visualization dashboards and regular performance reports to communicate accrual, safety, and outcomes metrics to investigators, sponsors, and departmental leadership, using tools such as Tableau or Power BI.
Act as the primary operational contact for sponsor interactions, CRO liaisons, and external collaborators; coordinate site initiation visits, monitoring visits, and ensure timely responses to audit findings and sponsor queries.
Lead endpoint definition and adjudication processes for complex outcomes in upper GI research (e.g., recurrence, progression-free survival, surgical complications), establishing adjudication committees and standardized review procedures.
Coordinate multimodal data integration efforts that combine clinical, imaging (CT/EUS), pathology, genomics, and procedural (endoscopy) data to support translational analyses and biomarker discovery initiatives.
Implement quality assurance processes including periodic data quality checks, discrepancy management, and corrective and preventive action (CAPA) plans to continuously improve study conduct and data reliability.
Draft budget justifications, resource plans, and study timelines; track study expenditures, process invoices, and support financial reconciliation and grant reporting as required for sponsored trials or investigator-initiated studies.
Provide training and mentorship to junior research staff, study coordinators, and clinical fellows on protocol procedures, data entry standards, specimen handling, and regulatory requirements specific to upper GI studies.
Coordinate imaging and pathology workflows by defining specimen requirements, communicating with histology labs, and supporting centralized review and scoring systems for tumor staging and biomarker assessment.
Facilitate multidisciplinary tumor board data preparation and follow-up reporting for enrolled patients, ensuring accurate capture of treatment decisions, outcomes, and changes in management that inform translational research endpoints.
Manage timelines and project plans for multiple concurrent studies, prioritizing tasks, identifying dependencies and risks, and ensuring on-time delivery of key milestones such as enrollment completion, interim analyses, and final study reports.
Serve as the subject matter expert for upper GI clinical definitions, staging systems (AJCC), and procedural coding, providing domain-specific guidance to data curation, trial design, and outcome interpretation.
Coordinate and support grant submissions and investigator-initiated protocols by compiling preliminary data, preparing methods sections, and supporting budget and resource descriptions aligned to upper GI research objectives.
Lead data transfer and sharing agreements (DTA/DUA) negotiations and implementation for multi-institutional collaborations while ensuring patient privacy, de-identification, and compliance with institutional data governance policies.

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.
Represent the Upper GI research program at internal meetings, external conferences, and stakeholder briefings to disseminate findings and attract collaborators.
Assist in preparation and submission of regulatory documents for industry-sponsored trials when acting as the local site study lead.

Required Skills & Competencies

Hard Skills (Technical)

Proficient in statistical programming and analysis with R and/or SAS; experience running survival models, Cox regression, Kaplan–Meier analyses, and propensity-score methods.
Strong SQL skills for complex querying and database manipulation across clinical datasets, registries, and EHR extracts.
Experience with electronic data capture systems and clinical trial platforms such as REDCap, Medidata Rave, or Oracle Clinical.
Familiarity with clinical trial management systems (CTMS), source document management, and site monitoring practices.
Knowledge of regulatory and compliance frameworks including GCP, ICH, IRB submission requirements, HIPAA, and human subjects protection.
Practical experience with clinical coding systems (ICD-10, CPT), AJCC staging, and oncology-specific outcome definitions.
Experience processing and managing biospecimens, working with biobanks, and coordinating sample logistics and quality control.
Working knowledge of data visualization and business intelligence tools such as Tableau, Power BI, or ggplot2 for R.
Ability to integrate multi-modal data (clinical, pathology, imaging, genomics) and transform heterogeneous datasets for analysis.
Experience preparing manuscripts, conference abstracts, and grant materials; strong scientific writing and figure preparation skills.
Familiarity with endoscopy terminology, procedural workflows, and common therapeutic and diagnostic equipment used in upper GI practice.
Competence with version control and reproducible research workflows (Git, RMarkdown, Jupyter notebooks) for transparent analysis.

Soft Skills

Strong written and verbal communication skills tailored to clinicians, statisticians, and external stakeholders.
Excellent attention to detail with an ability to maintain data accuracy and reproducibility in complex datasets.
Demonstrated project management and organizational skills with the ability to prioritize tasks across multiple studies and deadlines.
Collaborative team player who builds productive relationships across clinical, laboratory, and regulatory partners.
Problem-solving mindset with initiative to identify process improvements and implement practical solutions.
Adaptability to changing requirements in a fast-paced academic or clinical research environment.
Ethical judgment and integrity when handling sensitive patient data and reporting study results.
Ability to mentor and train junior staff, fostering a culture of continuous learning and quality improvement.
Effective presentation skills for scientific audiences and operational stakeholders.
Customer-service orientation when working with patients, clinical teams, and external sponsors.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in a relevant field such as Biology, Public Health, Biostatistics, Health Sciences, or a related discipline.

Preferred Education:

Master’s degree (MS, MPH) or PhD in Epidemiology, Biostatistics, Clinical Research, or a biomedical science preferred; clinical degree (MD) with research experience is advantageous for senior roles.

Relevant Fields of Study:

Epidemiology
Biostatistics
Clinical Research
Medicine / Surgery (with GI focus)
Molecular Biology / Translational Science
Public Health

Experience Requirements

Typical Experience Range: 2–5 years of relevant clinical research or data analysis experience for mid-level analyst roles; 5+ years for senior analyst positions.

Preferred: Prior hands-on experience with upper GI clinical research, oncology or surgical outcomes studies, proven track record of managing complex datasets, publishing peer-reviewed manuscripts, and coordinating multi-site trials or registries.