Research Coordinator (2449)

OrthoLoneStarDallas, TexasOn-siteFull-timeListed 2 days ago

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About this role

Research Coordinator – Orthopedic Clinical Research

Position Overview
We are seeking an experienced, highly organized Research Coordinator to support and coordinate clinical orthopedic research initiatives. This is a full-time, in-person position responsible for managing research studies, maintaining registry data, coordinating patient participation, and supporting the analysis, publication, and presentation of research findings.

The ideal candidate will have prior clinical research experience and advanced proficiency in SAS and Microsoft Excel. Experience working with electronic health records, REDCap, the American Joint Replacement Registry (AJRR), and large healthcare registry databases such as PearlDiver is required or strongly preferred.

Essential Duties and Responsibilities

Clinical Research Coordination
Coordinate clinical orthopedic research studies from study initiation through completion.
Assist with developing research protocols, study workflows, case report forms, and data-collection tools.
Identify, recruit, screen, and enroll eligible research participants.
Coordinate the informed-consent process in accordance with applicable policies and regulatory requirements.
Schedule and track study visits, procedures, surveys, and follow-up activities.
Monitor study timelines, enrollment goals, outstanding documentation, and required deliverables.
Serve as a primary point of contact among physicians, research participants, sponsors, and research staff.
Perform other duties and responsibilities as assigned to support the research program and the needs of the organization.

Data and Registry Management
Collect, enter, validate, clean, and maintain accurate research and patient data.
Manage data within REDCap and the American Joint Replacement Registry.
Perform routine data audits to identify missing, inconsistent, or inaccurate information.
Extract and organize clinical information from the electronic health record.
Use SAS and Microsoft Excel to manipulate, analyze, and report research data.
Work with large healthcare databases and registries, including PearlDiver or similar platforms.
Create reports, data summaries, dashboards, tables, and other materials for investigators and leadership.
Maintain appropriate data security, confidentiality, and access controls.

Regulatory and Compliance Responsibilities
Assist with Institutional Review Board submissions, renewals, amendments, and study closures.
Maintain complete and organized regulatory binders and study documentation.
Ensure research activities comply with approved protocols, Good Clinical Practice guidelines, HIPAA, and other applicable requirements.
Assist with sponsor monitoring visits, audits, and requests for documentation.
Track required training, approvals, consent forms, and regulatory deadlines.

Publications and Presentations
Conduct literature reviews related to orthopedic research topics.
Assist with statistical analysis and interpretation of research findings.
Prepare tables, figures, summaries, and supporting documentation for investigators.
Contribute to abstracts, manuscripts, posters, and presentations.
Coordinate submission deadlines and requirements for conferences and peer-reviewed publications.

Qualifications

Required Qualifications

Bachelors degree in biology, life sciences, healthcare, public health, data science, statistics, or a related field.
Previous professional experience coordinating clinical research studies.
Demonstrated knowledge of clinical research processes, research methodologies, and regulatory requirements.
Proficiency in SAS statistical software.
Advanced proficiency in Microsoft Excel, including formulas, data validation, pivot tables, lookups, data cleaning, and reporting.
Experience using an electronic health record system.
Experience with REDCap or a comparable research data-management system.
Strong data-management and data-manipulation skills.
Excellent organizational, written communication, and interpersonal skills.
Ability to manage multiple studies, priorities, and deadlines with minimal supervision.
Strong attention to detail and commitment to data accuracy and participant confidentiality.
Ability to work full time and in person.

Preferred Qualifications
Experience working in orthopedic clinical research.
Experience with the American Joint Replacement Registry.
Familiarity with PearlDiver or another large healthcare claims or registry database.
Experience managing joint-replacement or other orthopedic outcomes data.
Knowledge of Good Clinical Practice guidelines and Institutional Review Board processes.
Experience preparing scientific manuscripts, abstracts, posters, or conference presentations.
Clinical Research Coordinator certification, such as CCRC or CCRP.

Core Competencies
Research study coordination
Data analysis and integrity
Regulatory compliance
Project and deadline management
Critical thinking and problem-solving
Professional communication
Collaboration with physicians and clinical teams
Accuracy, confidentiality, and attention to detail

Work Requirements
Full-time, in-person position.
Regular interaction with physicians, clinical staff, research participants, and external research partners.
Ability to work independently while contributing effectively within a multidisciplinary team.