Clinical Monitor

Posted August 17, 2011
Business MED Institute, Inc.
Purdue Research Park of West Lafayette,
n/a
Position Type Full Time
Start Date Immediate Availability

Duties / Responsibilities

This individual is responsible for ensuring that global 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 global clinical study objectives on behalf of the Cook organization.

  • Indentify and report to project management 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 onsite 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 process and project management 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 exceding expectations.

Requirements / 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 global 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 collegial team atmosphere; including communicating and working constructively with colleagues; and
  • Willing and able to travel 50-75% of the time.

Company Description

MED Institute, Inc. was established as a resource for Cook Group companies to identify and develop new medical product concepts. This includes new product discovery, prototype development, nonclinical testing, clinical study management and data analysis, education for the medical community, and preparation of regulatory submissions. MED Institute employs a staff of research, medical, engineering, and administrative professionals.

Other

Benefits include 401k and profit sharing plans, health, dental, life and optical insurance, eight paid holidays per year, and vacation.

MED Institute is an Equal Opportunity Employer (EOE).

Application Instructions

Please e-mail resume to hr@medinst.com.

We accept Word documents and PDF's.