• Job Description

  Req#: 28627
  Job Title: Clinical Research Associate/Monitor
  
  6 months contract to perm
  
  Work location: REMOTE
  
  Required 30%-50% traveling
  
  Candidate home location: required within DC, VA, MD only (a candidate needs to reside in DC, VA, MD)
  
  Multiple Regional CRAs: 5 openings
  
  USC/GC required
  
  Search Term: Regional CRA, Contract CRA, Sr. CRA, Home-based CRA, Regional Clinical Research Associate, Regional CRA III, Sr. Clinical Research Associate, Senior Clinical Research Associate, Monitor, Contract CRA II, CRA III, Regional Monitor, Home-based Regional CRA, CRA, Contract Clinical Research Associate, Regional CRA Consultant, Phase I, Study Monitor, Contract Monitor, CRA, Research Associate
  
  Multiple Studies with Health patients - Previous Phase I experience required
  
  Contract CRAs, regional based with strong monitoring skills, minimum 3-5+ years monitoring experience within the pharmaceutical industry required traveling of minimum of 50% traveling to 1-2 sites within the same state as required. Require 100% commitment and contractors paid hourly. Therapeutic areas can range and candidates will be expected on working on about 6-8 protocols (max at 10 protocols) with different indications. Multiple sites and candidate has to be local to DC, VA, and MD areas.
  
  Minimum 3-5+ years of CRA / Monitoring experience required
  
  Start date is ASAP
  
  TRAVEL INFORMATION FOR CANDIDATES -
  
  The client is working to ensure candidates are as close as possible to their sites. Company is constantly adding new studies to the monitoring project. Monitors may be asked to take on additional sites closer to their home (or maybe a bit further then what they currently have) - they will work to keep travel as regionally located as possible. There are multiple sites in each region (depends on the allocation of the individual CRAs)
  
  In addition they should be very clear about their monitoring experience showing that they are a Regional CRA/monitor currently. (I would say 3 years monitoring experience with Oncology study required) Candidates need to allocate 50% to 100% of their time to this assignment, preferred candidates home is close to the site locations (listed above).The CRA/Study Monitor designated activities include site visits, trial monitoring, tracking, documentation, collection, solicitation and review of (e) CRFs and submit data, preparation of reports, regulatory review and participation in teleconferences. Approximately 50% travel will be required, as the CRA Study Monitor's primary responsibilities will be monitoring of study sites.
  
  Requirements
  
  A strong healthcare background with at least 1-2 years prior monitoring Oncology study experience is required. Phase I research experience as a monitor, auditor, research coordinator, research associate or similar oncology research experience is required. The CRA/Study Monitor must hold a Bachelor's degree from an accredited college or University or be a grad from an accredited school of nursing.
  
  Requirement:
  
  
  • 2+ years prior monitoring Oncology study experience is required. preferred. Phase I-IV research experience as a monitor, clinical research associate experience is required.
  • BS/BA in life sciences or health-related discipline, BSN, Bachelor of Science - Nursing, Pharmacy is highly desirable.
  • Minimum 3-5+ years clinical research monitoring experience including years in Phase I studies.
  • Strong working knowledge of GCPs, ICH Guidelines, and FDA Regulations
  • Ability and willingness to travel up to 50 % of the time, including minimum overnight stays travel as necessary
  • Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus
  • Experience with using a Trial Master File, a plus.

• About the company

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