Clinical Trial Specialist (Hybrid)
Piper Companies, Bethesda, MD, United States
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.
This is a short‑term assignment of 3+ months.
Responsibilities
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
Qualifications
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
Compensation
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
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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.
This is a short‑term assignment of 3+ months.
Responsibilities
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
Qualifications
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
Compensation
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
#J-18808-Ljbffr