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In-House Clinical Research Associate (CRA)

Job Attributes

Job Id:

16631

Job Category:

Clinical & Life Sciences

Job Location:

Rockville, MD  20850

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Clinical Solutions is currently seeking an In-House Clinical Research Associate (CRA) in the Montgomery County, MD area. This person will support multiple ground-breaking clinical research trials for a growing pharmaceutical company!

 

Requirements for the In-House CRA

  • Reviews site regulatory documents and maintains required study files
  • Ensures proper procedure for reconciliation documents for database locks
  • Provides expertise for trial documentation tracking, from site performance, study drugs, and material reconciliation
  • Ensures regulatory compliance with SOPs, FDA guidelines, and ICH
  • Works with sites on Electronic Data Capture (EDC) systems for accuracy and completeness
  • Reviews processes for safety and ensures reporting of SAE (serious adverse events) to appropriate regulatory bodies  
  • Reviews Informed Consent Forms (ICF’s)
  • Helps sites design case report forms (CRF’s), procedure manuals, source documents, ICF’s and more

Qualifications of the In-House CRA

  • 4+ years of experience as a CRA or monitor
  • Oncology background preferred
  • Experience tracking study supplies
  • Understanding of lab samples and PLC
  • Bachelor’s Degree

Compensation for the In-House CRA

  • Salary: up to $90,000 (commensurate with experience)
  • Benefits: Medical, Dental, Vision, 401k

 

Please send all qualified resumes to Michael Epstein at mepstein@pipercompanies.com

 

Keywords: Clinical research associate, clinical research, medical monitor, study monitor, clinical monitor, informed consent form, ICF, standard operating procedure, SOP, electronic data capture, EDC, oncology, regulatory documentation, regulatory affairs, in house CRA, CRA, in-house CRA, IRB, institutional review board, source documents, pharmaceutical research, clinical study, research study, medical, dental, vision, 401k

 

 

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Job Id:

16631

Job Category:

Clinical & Life Sciences

Job Location:

Rockville, MD  20850

Security Clearance:

No Clearance

Business Unit:

Piper Companies