Clinical Monitor

Posting Date 3 weeks ago(9/2/2022 9:14 AM)
Requisition ID
2022-11432
Job Location(s)
West Lafayette IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Med Institute Inc.
Category
Clinical

Overview

This individual is responsible for ensuring clinical studies are being conducted in accordance with the study plan/protocol, applicable regulations and signed investigator agreements at each investigative site in order to meet clinical study objectives on behalf of clients.

Responsibilities

  • Identify and report to the Project Leader any issues which may need attention at a particular investigative site; support resolution as needed;
  • Travel to investigative sites to perform site initiation, periodic and closeout visits, including assessment of study resources, review of on-site data and source documentation, assessment of adherence with the study plan/protocol and applicable regulations, and general support of the physician and his/her research staff;
  • Generate detailed and timely site visit reports following each site visit;
  • Support the development of study plans/protocols, data collection forms, patient summaries and other study-related documentation as needed;
  • Work closely with both the Project Leader and the client to determine priorities and ensure that project objectives are met; and
  • Establish trusted relationships with physicians, their research staff, the project team and study sponsors through communication and a commitment to exceeding expectations.

 

Qualifications

  • RN with BSN or MS in Health or Life Sciences required;
  • Prior experience in monitoring or auditing, preferably in a clinical application;
  • Working knowledge of FDA and other regulatory requirements that may impact clinical studies;
  • Conscientious, influential person with an outstanding work ethic and strong personal discipline;
  • Willingness and capability to handle multiple projects and responsibilities;
  • Sufficiently assertive to deal with confrontational situations;
  • Excellent organizational, leadership and problem-solving skills;
  • Excellent written and verbal communication skills;
  • Ability and desire to work in a collegiate team atmosphere; including communicating and working constructively with colleagues; and
  • Willing and able to travel, as needed.
  • Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

 

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