Clinical Monitor - UK

Reference:

Job Type: Permanent
Location:
Salary: Competitive

Start Date: March 2012

Clinical Monitor - Job Description

Clinical

Reviews clinical trial data and ensures it is accurate, complete, clear, and verifiable from source documents
Verifies the conduct of trial is in compliance with the currently approved protocol/amendment(s), GCP and applicable regulatory requirements; Communicates any deviations to the investigator and sponsor as necessary to secure compliance
Maintains a direct line of communication with the investigator on behalf of the sponsor
Verifies that all research staff have adequate qualifications and resources and that facilities remain acceptable for conduct of the study
Verifies that the rights and well being of human subjects are protected.
Verifies investigational devices are secure and accountability is accurate, complete and maintained
Verifies that adverse events are reported in accordance with protocol requirements
Communicates visit expectations and findings according to the timeline and other requirements of the monitoring plan
As requested, ensures monitoring action items are closed out and corrective action plans completed.
As requested, provides training to the sites at the site initiation visit and ongoing training and support as needed
As requested, performs qualification visits to determine if sites meet pre-defined criteria for trial participation.

Other Job Requirements:

Open and clear communicator (oral and written)
Bilingual (English and German preferred)
Solves routine problems.
Provides interdepartmental support as needed, e.g., copying, document assembly, receptionist duties.
Enters time into accounting database including client billing and administrative time.
Dresses in a professional manner.
Interacts with employees, clients and vendors in a professional and courteous manner.
Keeps managers and project managers informed as appropriate.
Follows written and verbal work direction and priorities from manager.
All duties and responsibilities require review by manager.
Travels as required (up to 80%) to meet project and sales and marketing objectives.

Knowledge, Skills and Abilities Required:

High School Diploma (GED) + 4 - 7 years of relevant experience or successful completion of the Associate Clinical Monitor program.
AA Degree + 2 - 5 years of relevant experience or successful completion of the Associate Clinical Monitor program..
BA/BS Degree + 0 - 3 years of experience.
Masters Degree + 0-2 years experience.
Ability to establish priority and balance one's own workload.
Ability to understand medical records and terminology pertaining to a variety of medical conditions.
Ability to speak, read and write fluently in English and German at the high school (GED) level, including ability to interpret handwriting from site documents.
Ability to use a computer keyboard is required.
Basic word processing and spreadsheet skills.
Vision needs to be sufficient to read documents including drawings and sketches.
Monocular vision and lack of depth perception do not disqualify.
Auditory acuity must permit conversations with key personnel on the telephone and in person.

Applications are handled online where you will be able to upload your CV.