What are the responsibilities and job description for the Clinical Trial Specialist (Hybrid) position at Piper Companies?
Piper Companies is seeking a Clinical Trial Specialist (IRB) to support a well-established CRO in Bethesda, MD. This role is hybrid (2 days on-site) and will play a key role in supporting clinical trial operations by ensuring the TMF is accurate, compliant and audit-ready.
Keywords:
Clinical Research, Clinical Research Coordinator, CRC, CRA, Clinical Research Assistant, Clinical Trial Assistant, CTA, Clinical Trial, Clinical Operations, Study Support, Patient Recruitment, Enrollment, Trial Administration, TMF, Trial Master File, eTMF, electronic Trial Master File, Redcap, Medidata, Veeva, VeevaVault, EDMS, CTMS, Clinical Trial Management System, Study Start Up, SSU, Site Management, Document Processing, TMF Maintenance, TMF Completeness Checks, Essential Documents, Regulatory, Inspection Readiness, Audit Preparation, Regulatory Binder, Document Archival, IRB, Institutional Review Board, IRB Submission, Regulatory Submission, ICH, ICF, CRF, Informed Consent Form, Case Report Form, Clinical Research Coordinator, Regulatory Associate, Regulatory Specialist, Research Assistant, Medidata, RAVE, REDCap, Regulatory Binder, SOP, Standard Operating Procedure, Document Tracking, ICH, GCP, Good Clinical Practice, FDA, EMA, Compliance Monitoring, IRB, Study Correspondence, Data Entry, Data Analysis, CRO, Clinical Research Organization, Pharmaceutical, Biotechnology, Site Monitoring, EDC, Electronic Data Capture, RAVE, Enrollment Tracking, Study Metrics, Trial Interactive, Wingspan, Excel, Study Dashboard, Document Tracking Log, ICF, Informed Consent Form, Protocol, Investigator Brochure, Study Timeline, Safety Reporting, Source Documents, Adverse Events, SAE, AE, Adverse Event, Clinical, Research, Infectious Disease, Oncology, Cardiology, Immunology, Contract, Hybrid
- This is a short-term assignment of 3 months
- Maintain, organize, and track all regulatory documents (IRB submissions, renewals, amendments, CRF, ICF, etc..)
- Perform routine quality checks and provide TMF metrics and status reports to internal teams and sponsors
- Ensure timely filing, retrieval, and delivery of clinical trial documents
- Support audit and inspection readiness activities
- Contribute to updates of SOPs, work instructions, and training materials related to TMF processes
- 1-3 years of regulatory submission/IRB experience working for a CRO, pharmaceutical/biotech, or research institution
- Must have prior IRB submission/regulatory experience
- Strong database experience in Veeva Vault, eTMF, RedCap, Medidata, eCRF, etc.
- Bachelor’s degree in science related field
- Salary: $50,000 - $62,000 annually, commensurate with experience
- Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave required as by law, PTO, Holidays
Keywords:
Clinical Research, Clinical Research Coordinator, CRC, CRA, Clinical Research Assistant, Clinical Trial Assistant, CTA, Clinical Trial, Clinical Operations, Study Support, Patient Recruitment, Enrollment, Trial Administration, TMF, Trial Master File, eTMF, electronic Trial Master File, Redcap, Medidata, Veeva, VeevaVault, EDMS, CTMS, Clinical Trial Management System, Study Start Up, SSU, Site Management, Document Processing, TMF Maintenance, TMF Completeness Checks, Essential Documents, Regulatory, Inspection Readiness, Audit Preparation, Regulatory Binder, Document Archival, IRB, Institutional Review Board, IRB Submission, Regulatory Submission, ICH, ICF, CRF, Informed Consent Form, Case Report Form, Clinical Research Coordinator, Regulatory Associate, Regulatory Specialist, Research Assistant, Medidata, RAVE, REDCap, Regulatory Binder, SOP, Standard Operating Procedure, Document Tracking, ICH, GCP, Good Clinical Practice, FDA, EMA, Compliance Monitoring, IRB, Study Correspondence, Data Entry, Data Analysis, CRO, Clinical Research Organization, Pharmaceutical, Biotechnology, Site Monitoring, EDC, Electronic Data Capture, RAVE, Enrollment Tracking, Study Metrics, Trial Interactive, Wingspan, Excel, Study Dashboard, Document Tracking Log, ICF, Informed Consent Form, Protocol, Investigator Brochure, Study Timeline, Safety Reporting, Source Documents, Adverse Events, SAE, AE, Adverse Event, Clinical, Research, Infectious Disease, Oncology, Cardiology, Immunology, Contract, Hybrid
Salary : $50,000 - $62,000