Clinical Research FastrackClinical Research Trainee
Mar. 2023 - Jun. 2023North Atlanta, Georgia, United States · Remote1. ICH GCP E6 R2
2.FDA Regulations 21 CFR Parts 11, 50, 54, 56
3. Data Management Systems, Electronic Data Capture (EDC) systems like MedRio, Medidata, InForm
4. Informed Consent Process
5. Clinical Trial Operations from feasibility through close-out (Site and Sponsor/CRO responsibilities and duties)
6. GDP following ALCOA-C principles
7. Identification and reporting of AEs and SAEs
8. Quality Assurance, Monitoring and Query Resolution
9. Comprehension and Execution of Clinical Trial Protocols
10, Maintaining regulatory binder, housing essential documents including but not limited to 1572, Source documents, DOA, Training Logs, ICF, SAE forms, Financial Disclosures, Subject Enrollment & Identification Logs, Case Report Forms (CRF), Procedure Manuals, Standard Operating Procedures (SOP), Site Visit Logs, Corresppondences, Trial Master Files (TMF), and other Investigator Site File (ISF) documents