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Job Posting Title:

Location:

Additional Posting Details:

Monday - Friday,

8:00am - 4:00pm

Job Description:

Duties/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.

Required Skills/Abilities

• Bachelor's degree required.

• 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.

• 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.

Preferred Qualifications for Advanced/Senior Research Coordinators

• 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.

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