Clinical Research Analyst

Clinical Research Analyst

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The Clinical Research Analyst is responsible for coordinating and managing aspects of NIH- and industry-sponsored clinical research studies within the Department of Neurology, with a focus on neuromuscular diseases. Working under the direction of the Principal Investigator(s) and Clinical Research Manager, the Clinical Research Analyst ensures the successful implementation of clinical research protocols while maintaining compliance with institutional, sponsor, FDA, IRB, and Good Clinical Practice (GCP) requirements.

This position serves as a primary liaison among study participants, investigators, sponsors, clinical staff, and regulatory agencies to support the timely and successful completion of clinical research projects.

Assist with coordination of all phases of clinical research studies from study start-up through closeout.

Screen, recruit, consent, enroll, and retain study participants in accordance with approved research protocols.

Schedule and coordinate participant visits, procedures, laboratory testing, and follow-up assessments.

Collect, review, and maintain accurate clinical research data and source documentation.

Enter and reconcile study data in electronic data capture systems while ensuring data quality and integrity.

Assist with preparation and submission of IRB applications, amendments, continuing reviews, adverse event reports, and other regulatory documents.

Maintain study files and essential documents in accordance with institutional and sponsor requirements.

Coordinate sponsor monitoring visits, site initiation visits, audits, and closeout activities.

Ensure compliance with FDA regulations, Good Clinical Practice (GCP), HIPAA, institutional policies, and human subjects protection requirements.

Communicate regularly with investigators, study sponsors, contract research organizations (CROs), research participants, and multidisciplinary clinical teams.

Assist with protocol feasibility assessments, study activation, and implementation of new clinical trials.

Track study enrollment, budgets, timelines, and milestone completion to ensure contractual and grant deliverables are met.

Prepare reports and assist investigators with study progress updates and sponsor communications.

Perform other related duties as assigned to support the clinical research program.

Demonstrated experience with patient recruitment and obtaining informed consent.

Excellent written and verbal communication skills. Strong organizational, analytical, and problem-solving skills with exceptional attention to detail.

Ability to prioritize multiple studies, manage competing deadlines, and work independently in a fast-paced research environment.

Proficiency with Microsoft Office Suite.

Proven experience with electronic clinical research systems, including REDCap, Oncore and electronic data capture (EDC) platforms.

Proven experience with EPIC.

Works closely with investigators and other study team members including the project manager, for projects or programs of a small size or sections of medium projects and programs to consult, conduct analysis, and identify trial objectives and requirements within specific parameters.

Interprets research business needs and translates them into application and operational requirements for a specific area(s) of research. Develops necessary tools and workshops to successfully elicit requirements.

Critically evaluates information gathered from multiple sources – research protocols, clinical trial agreements, financial budgets and fees associated with research - to reconcile conflicts, and decompose high-level information into data essentials.

Analyzes data with standard methods, interprets the results, and provides written summary and reporting…