Clinical Research Coordinator
4 weeks ago
Title: Clinical Research Coordinator
Duration: 12 months contract with possible extension
Location: Bethesda MD (On-Site)
Work Details:
- Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices.
- Prepare and submit for review accurate source documents related to all research procedures.
- Prepare and submit Case Report Forms (CRFs) and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields.
- Enter data into research databases, systems and applications for ongoing studies.
- Assist researchers with study testing, observations data entry and other duties associated with study sessions.
- Supports clinical staff develop, implement and maintain clinical research data files and materials.
Minimum Education
- Bachelor
Certifications & Licenses
- Association of Clinical Research Professionals Certified Professional (ACRP-CP)
- Association of Clinical Research Professionals (ACRP)
- Certified Clinical Research Professional (CCRP)
- Certified Clinical Research Coordinator (CCRC)
- Certified Clinical Research Associate (CCRA)
Field of Study
- Miscellaneous Health Medical Professions
- Nursing - Community and Public Health
- General Medical and Health Services
- Neuroscience
- Miscellaneous Biology
- Cognitive Science and Biopsychology
- Genetics
- Health and Medical Preparatory Programs
- Nutrition Sciences
- Pharmacy Pharmaceutical Sciences and Administration
- Treatment Therapy Professions
- Communication Disorders Sciences and Services
- Sociology
- Miscellaneous Social Sciences
- Interdisciplinary Social Sciences
- General Social Sciences
- Miscellaneous Psychology
- Clinical Psychology
- Psychology
- Social Psychology
- Social Work
- Chemistry
- Multi-Disciplinary or General Science
Software
- Clinical Trial Management System (CTMS)
- Electronic Medical Records System
- Electronic Data Capture System
Skills
- Overseeing and documenting IP dispensing, inventory and reconciliation
- Closing clinical trial sites down on completion of clinical trial
- Ordering, tracking, and managing IP and trial materials
- Implementation of clinical trial site action plans
- Training clinical trial site staff
- Coordinating project meetings
- Previous clinical trial work
- Electronic medical records
- Protocol review revision
- Phase I or II experience
- Patient confidentiality
- Remote site monitoring
- Regulatory compliance
- Protocol development
- Clinical Research
- Protocol writing
- Clinical Trials
- Data Monitoring
- Data Integrity
- Patient care
- Recruitment
- Scheduling
- Screening
- Research
- ICH/GCP
- SOPs
- Liaising with regulatory authorities
- Liaise with ethics committee
- Protocol navigation
- Regulatory affairs
- IRB submissions
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