четверг, 19 сентября 2013 г.

Clinical Trial Coordinator at Saint Paul

Job Description

Clinical Trial Coordinator

Galil Medical is currently seeking an experienced Clinical Trial Coordinator to join our team in Minneapolis, MN.

Job Description:
The primary purpose of the CTA is to administer, maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). They also act as a pivotal point of contact & support for the clinical trial team. The CTA will be involved in most activities in preparation for study set up, conduct and completing a Clinical Trial.

Job Responsibilities:
  • Managing study site, consulting, or vendor contract agreements (e.g. obtain signatures, distribute copies, filing, renewal schedule)
  • Arranging & participating in the organization of Investigator Meetings & Study Team Meetings. Taking minutes & distributing.
  • Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.
  • Preparing Protocols, Investigator Brochures and CRFs which includes keeping track and re-ordering supplies.
  • Set up and maintenance of the Trial Master Files (TMF) or Electronic filing systems/ set up of the Investigator Site File (ISF)
  • Managing and maintaining study documents & trial supplies
  • Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return.
  • Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial
  • Create & maintain study contact lists for team/sites/3rd parties/set up mail merges.
  • Sending out Study Newsletters / Study Correspondence to all participating sites on an ongoing basis as requested.
  • Setup of clinical finance systems accurately, processing invoices & tracking payments for the trial for investigator payments.
  • Assist with collating and shipping CRFs & data queries to Data Management
  • General study filing
  • Coordinating archiving of study documentation

Job Requirements

Education and Experience:
  • High School diploma or equivalent required, BA degree preferred
  • Previous experience in clinical research preferred
  • Secretarial/Administration experience
Skills and Abilities:
  • IT literacy, particularly in MS Word, Excel and PowerPoint
  • Personal Skills (description of the personality characteristics required for this position)
  • Quick to learn
  • Excellent organizational skills
  • Good attention to detail
  • Work under pressure and to deadlines
  • Pro- active, flexible and able to multi-task
  • Self-motivated
  • Work well in a team and independently
  • Excellent time management
  • Excellent communication (written and oral) and vendor-management skills


Compensation and Benefits:
  • Compensation is commensurate with experience
  • Benefits package available

To Apply:
Please submit your resume via the "Apply Now" button.

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Equal Opportunity Employer

Country: USA, State: Minnesota, City: Saint Paul, Company: Galil Medical.

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