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 Job #02217 Email this job to a friend
About our client
Our client is a progressive manufacturer and distributor of a wide spectrum of drugs and medical devices. The company has been in operation for more than nine and a half decades.
Position Location
Clinical Research Associate Pennsylvania
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Assist with administration of clinical research projects like recruiting investigators, collecting investigator documentation, site management, and preparing status reports
2) Oversee completion of routine technical tasks
3) Initiate, monitor, and close-out clinical investigative sites under supervision from Project Managers and Project Directors
4) Assist and manage training of new Clinical Research Associates
5) Provide ongoing assistance and education of investigational sites in clinical research
6) Update, track, and maintain study specific trial management tools/system
7) Monitor Case Report Forms (CRF) for missing implausible data
8) Assist sites in maintaining Good Clinical Practices (GCP)
9) Write narratives and follow-up on reported serious adverse experiences
10) Assist with generation and reconciliation of queries to investigation sites for resolving problem data
11) Assist and manage project budget and investigator/site budget
12) Attend project team meetings and communicate with clients
13) Plan and attend investigator meetings
14) Generate and track drug shipments and storage
15) Provide coverage to clinical contact telephone lines
16) Perform other duties assigned by management
Requirements
1) BS degree in Clinical or Biological Science
2) Minimum 2 years' CRA monitoring experience
3) 1-2 years' experience in drug development, regulatory affairs, etc.
4) Knowledge of MS Word, Excel, medical/regulatory terminology
5) Dialysis, rheumatology, oncology, cardiology, or GI experience preferred
6) Excellent written and verbal communication skills
7) Ability to travel as needed

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