MedFocus Sr. CRA in New Jersey

SCOPE OF ASSIGNMENT Coordinate and perform comprehensive Quality Control (QC) of CRO managed investigative sites. As needed, perform site management of Company clinical trials. DUTIES AND RESPONSIBILITIES

  • Oversee and evaluate CRO monitoring activities through electronic data capture (Medidata Rave), electronic diaries ), patient enrollment , site monitoring, review of monitor visit reports and review

  • of status in CRO CTMS

  • Perform QC of CRO Monitor Visit Reports; maintain issue and resolution log

  • Conduct QC visits at investigative sites, identify and follow-up on site action items, prepare QC visit report

  • As requested coordinate and perform site booster visits and co-monitoring visits

  • Provide input into study plans (i.e., Monitoring Plan, Quality Plan)

  • Attend and/ or participate in investigator meetings (planning, execution and presentations)

  • Interface with investigators, study coordinators, and study personnel via telephone, written correspondence and on-site visits.

  • As needed perform CRA Monitoring Responsibilities for Company clinical studies o Interface with investigators, study coordinators, and study personnel via telephone, written

  • correspondence and on-site visits

  • Coordinate and disseminate information to site staff (i.e., study protocol, CRFs)

  • Monitor study protocol(s). Collect and review regulatory documents and perform source

  • document verification.

  • Provide verbal reporting of any serious adverse events related to the study project.

  • Complete QC trip reports and other required forms. Provide documentation for related

  • correspondence.

  • Participate in targeted QC of Trial Master File

Minimum REQUIREMENTS: 6+ years of CRA/monitoring experience 4 year degree

Min Salary: $0.00

Max Salary: $0.00

State: NJ