Research Coordinator

Scottish Rite for Children•Dallas, TX

6d•Onsite

About The Position

Our patients are our number one priority! We're committed to giving children back their childhood! This role involves collaborating with various research divisions and clinical departments to gather necessary information and support for research activities. The Research Coordinator will organize meetings, communicate study updates, and provide reports to Principal Investigators. Key responsibilities include performing literature reviews, assisting with study design, preparing regulatory documents, and managing submissions to the Institutional Review Board (IRB) and other regulatory agencies. The position requires executing approved study protocols, maintaining regulatory binders and study files, and ensuring readiness for audits. The coordinator will also be responsible for screening, recruiting, consenting, and enrolling participants, coordinating study visits and procedures, and collecting and entering research data using systems like REDCap and electronic medical records. Additionally, the role involves generating reports for statistical analysis, assisting with publications and grant applications, participating in audits, and training research staff. Reading relevant literature and attending conferences are also part of the role, along with supporting research activities across different departments and performing other assigned duties.

Requirements

Bachelor's degree required.
Proficiency in Microsoft Office.
Strong organizational, time management, and project coordination skills with the ability to manage multiple studies simultaneously.
Excellent communication, problem-solving, critical thinking, and attention to detail.
Ability to work independently while collaborating effectively with multidisciplinary teams.
Self-motivated, adaptable, resourceful, and able to thrive in a fast-paced research environment.
Capable of recruiting research participants in person, by phone, and virtually.

Nice To Haves

Prior clinical research and regulatory experience strongly preferred; three years of clinical research experience preferred.
Certification as a Certified Clinical Research Professional (CCRP) preferred.
Working knowledge of Good Clinical Practice (GCP), Human Subjects Protection, IRB processes, and clinical research regulatory requirements preferred.
Experience with REDCap or other electronic data capture systems preferred.
Experience with electronic medical records, particularly Epic, preferred.
Candidates with experience in IND/IDE studies, audit readiness, quality management, CAPA development, multi-site study coordination, SOP development, staff mentoring, project management, and sponsor interactions are encouraged to apply.

Responsibilities

Collaborate with staff in other research divisions and clinical departments within Scottish Rite to obtain the information and support necessary to conduct research.
Organize and lead project meetings, communicate study updates, and provide regular reports to Principal Investigators.
Perform literature reviews, assist with study design, prepare regulatory documents, consent forms, and research submissions for presentations and publications.
Prepare, submit, and maintain regulatory documentation with the Institutional Review Board (IRB), Research Advisory Panel, and other applicable regulatory agencies, including initial submissions, continuing reviews, amendments, and study closures, while ensuring compliance with Good Clinical Practice (GCP), Human Subjects Protection, and applicable regulatory guidelines.
Develop and maintain project timelines, communicate barriers proactively, and coordinate with research teams to ensure milestones and deadlines are achieved.
Execute approved study protocols in accordance with GCP, institutional policies, and study requirements.
Maintain regulatory binders, source documentation, and study files; manage reportable events, protocol deviations, adverse events, and audit readiness for internal, sponsor, and regulatory inspections.
Screen, recruit, consent, and enroll research participants while ensuring compliance with study protocols and regulatory requirements.
Coordinate study visits and procedures, including clinic visits, questionnaires, laboratory collections, imaging, and other protocol-required assessments.
Monitor participant follow-up and protocol compliance.
Collect, enter, and maintain accurate research data using REDCap, electronic data capture systems, electronic medical records (Epic preferred), and study databases to ensure data quality and integrity.
Resolve data queries and maintain study documentation.
Generate reports and organize data for statistical analysis.
Assist with the preparation and submission of abstracts, posters, presentations, manuscripts, and grant or funding applications.
Participate in internal, sponsor, and regulatory audits; identify process improvement opportunities and support corrective actions as appropriate.
Participate in onboarding, training, and coordinating research staff, interns, students, residents, and fellows.
Read literature relevant to pediatric medical and surgical conditions and attend conferences and educational meetings supporting ongoing research initiatives.
Support research activities across divisions, departments, or campuses as needed.
Perform other duties as assigned.