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Clinical Research Coordinator I
Nationwide Children's Hospital. Manage elements of clinical studies to meet protocol obligations while following ICH/GCP guidelines and institutional standard operating procedures .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical studies, adhering to ICH/GCP guidelines, and performing laboratory assessments. Proficient in data collection, regulatory compliance, and effective communication with patients and research teams.
Highest-signal resume keywords
Clinical Study ManagementCRA/CRC CertificationCLIA-Waived Laboratory AssessmentsData Collection and ManagementMedical Terminology Understanding
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ResearchData ManagementLaboratory Analytical ProceduresSample CollectionProtocol ExecutionRegulatory ComplianceScreening Sheets CompletionSource Document CreationStudy Start-Up ActivitiesSubject Enrollment
Soft Skills
Analytical SkillsAttention to DetailVerbal CommunicationWritten CommunicationOrganizational SkillsInterpersonal SkillsTeam Player
Tools & Technologies
Word Processing SoftwareData Management SoftwarePCs
Certifications & Qualifications
CRA CertificationCRC Certification
Industry Keywords
ICH GuidelinesGCP GuidelinesClinical TrialsRegulatory BindersPatient AdvocacyQuality Control Guidelines
About the role
Key responsibilities & impact- Manage elements of clinical studies to meet protocol obligations while following ICH/GCP guidelines and institutional standard operating procedures
- Perform study start-up, launch, day-to-day management, and closure activities
- Recruit, consent, and enroll subjects according to regulations and institutional requirements
- Answer protocol-related questions and act as a patient/family advocate
- Verify inclusion/exclusion criteria and alert investigators to safety concerns, protocol deviations, or premature termination requests
- Collect and manage research data and subject information, including laboratory analytical procedures
- Prepare and process human specimens for research studies
- Collect blood, urine, and other samples as needed
- Perform CLIA-waived laboratory assessments
- Complete screening sheets and recruitment logs
- Create source documents for systematic data collection, protocol execution, management, and record keeping
- Conduct accurate and timely subject data collection
- Collaborate with hospital services and the PI/sub-I to coordinate and schedule study visits
- Adhere to departmental quality control guidelines
- Complete sponsor Case Report Forms (CRFs) before monitoring visits
- Maintain regulatory binders and documents
Requirements
What you’ll need- Associates degree, STNA, PCA, LPN, MA or equivalent work-related experience required
- BA/BS preferred
- Ability to obtain CRA/CRC certification in a timely manner
- Understanding of medical terminology and clinical research preferred
- Working knowledge of PCs, word processing, and data management software
- Demonstrated analytical skills with accuracy and attention to detail
- Excellent verbal and written communication skills
- Goal-oriented and self-directive
- Strong organizational and interpersonal skills
- Ability to actively participate as a team player
- Previous experience in clinical research or health care related field preferred
- Ability to collect blood, urine, and other samples according to skill level and certifications
- Ability to perform CLIA-waived laboratory assessments
- Ability to work occasional evening and weekend hours when required