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In-House CRA

Job Attributes

Job Id:

30763

Job Category:

Biotechnology

Job Location:

Rockville, MD  20850

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Piper Clinical Solutions is currently seeking a motivated In-House CRA local to the DMV area to support a biopharmaceutical company with a long term, multi-continental, ongoing oncology clinical research trial.


Responsibilities for the In-House CRA:

  • Conducts qualification, initiation, interim, close-out, and when warranted, co-monitoring visits
  • Initiate protocols and ensure all clinical aspects of trials are carried out in accordance to established protocols and adhere to Good Clinical Practices (GCP)/International Conference of Harmonization (ICH) guidelines
  • Review site regulatory documents and maintain required study files
  • Work with Principal Investigators (PI’s) and study staff to ensure appropriate operation and documentation of trials including site performance, tracking study drug and other study-specific material
  • Assure regulatory compliance of investigational sites with company SOPs, the FDA, IRB, and ICH guidelines
  • Monitor electronic data capture (EDC) systems and generate/resolve queries in clinical databases with clinical sites and/or through CRO’s to ensure proper reporting of Adverse Events (AE’s) and any additional follow-up needed
  • Contribute to the safety review process for clinical trials to ensure proper reporting of Adverse Events and Serious Adverse Events (SAEs), and coordinate presentation of information to Safety Monitoring Committees
  • Design study documents including, case report forms (CRF’s), site study procedure manuals and source documents/worksheets, monitoring plans, tracking tools, and informed consent forms (ICF’s)
  • Provide monitoring guidance and support to CRA’s in the field and in-house staff and assess CRO activities related to site management, data management, and pharmacovigilance


Requirements for the In-House CRA:

  • 3+ years of CRA experience (specific to the pharma industry)
  • 2+ years oncology trials experience
  • Experience managing multiple clinical trials 
  • Strong knowledge and experience with FDA, IRB and ICH regulatory protocols, vendor management, and document management


Compensation for the In-House CRA:

  • Salary based on meeting of requirements
  • Benefits: Health, Dental & Vision Insurance, 401K

 


 

Keywords:

International Conference on Harmonization, ICH, IRB, international review board, Good Clinical Practice, GCP, regulatory affairs, clinical research associate, cra, fda, food and drug administration, site management, cro, clinical research organization, site monitoring, clinical trials, clinical research, pharmaceutical, biotechnology, crf, informed consent, regulatory protocols, regulatory affairs, site visits, regulatory documentation, study management, sop, standard operating procedures, trial master file, tmf, tcf, monitoring guidelines, oncology, veeva vault, bioclinica, rave, 

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Job Id:

30763

Job Category:

Biotechnology

Job Location:

Rockville, MD  20850

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions