Note: The job is a remote job and is open to candidates in USA. SMARTFOX is seeking an experienced Clinical Research Coordinator to support and coordinate clinical research studies from initiation through completion. The role manages study start-up, participant recruitment and visits, regulatory documentation, clinical trial data, compliance, and coordination with investigators, sponsors, CROs, and healthcare teams.
Responsibilities
- Coordinate day-to-day activities for clinical research studies in accordance with study protocols, GCP, FDA regulations, and institutional policies
- Support study start-up activities, including regulatory submissions, site documentation, investigator files, and study materials
- Recruit, screen, enroll, and coordinate study participants according to approved protocols
- Schedule and coordinate participant visits, assessments, laboratory procedures, and follow-up activities
- Maintain accurate and complete clinical research records, source documents, and study databases
- Collect, enter, review, and reconcile clinical trial data while ensuring accuracy and data integrity
- Coordinate with Principal Investigators, physicians, nurses, laboratories, sponsors, and CROs throughout the study lifecycle
- Prepare and maintain IRB/IEC submissions, informed consent documentation, protocol amendments, and regulatory files
- Ensure informed consent is properly obtained and documented before study-related procedures
- Track study milestones, patient enrollment, protocol deviations, adverse events, and follow-up activities
- Assist with monitoring visits, audits, inspections, and resolution of data queries
- Maintain compliance with ICH-GCP, FDA regulations, HIPAA, and institutional SOPs
- Identify and escalate protocol deviations, safety concerns, and compliance issues to appropriate stakeholders
- Prepare study reports, tracking logs, recruitment reports, and other clinical research documentation
Skills
- Bachelor's degree in Life Sciences, Nursing, Healthcare, Public Health, Clinical Research, or a related field
- 3–4 years of experience in clinical research or clinical trial coordination
- Strong understanding of ICH-GCP, FDA regulations, IRB processes, informed consent, and clinical research procedures
- Experience working with clinical trial documentation, patient records, and research databases
- Strong organizational, communication, documentation, and time-management skills
- Ability to manage multiple studies, priorities, and deadlines in a fast-paced healthcare/research environment
- Proficiency with Microsoft Office, particularly Excel and Word
- Experience with EDC systems such as REDCap, Medidata Rave, or Oracle Clinical
- Familiarity with CTMS, eTMF, and clinical trial management platforms
- Knowledge of clinical trial phases (Phase I–IV)
- Experience with HIPAA, FDA 21 CFR Part 11, and adverse event reporting
- Clinical Research Coordinator certification such as ACRP-CP or CCRC is preferred
- Experience working with pharmaceutical companies, CROs, academic medical centers, or healthcare organizations
Benefits
- Remote - United States
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