Senior Clinical Research Associate - Rockville, MD

Only for registered members Rockville, MD , United States

2 weeks ago

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Job summary

The Senior Clinical Research Associate (CRA) is responsible for monitoring clinical study sites either on-site at investigative sites or remotely to ensure clinical trials are conducted, recorded and reported in accordance with the protocol standard operating procedures SOPs ICH GCP and all applicable regulatory requirements.

Responsibilities

  • Under minimal supervision of the project CRA staff oversight lead independently schedules and conducts remote and on-site monitoring visits such as qualification/pre-study visits site initiation visits interim/routine monitoring visits closeout visits and for-cause visits.
  • As part of the site visits independently conducts Informed Consent ICF review source data verification/source document review review for compliance with required reporting/tracking of adverse events and protocol deviations investigator site file review laboratory tour specimen storage assessment pharmacy/Investigational Product IP/Investigational Device ID storage location tour storage condition assessment IP/ID accountability facilities tours

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