Clinical Research Associate

Posting Date 3 weeks ago(9/2/2022 9:30 AM)
Requisition ID
2022-11433
Job Location(s)
West Lafayette IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Med Institute Inc.
Category
Clinical

Overview

This position is responsible for supporting the daily activities of clinical studies to ensure they are being conducted, recorded, and reported in accordance with the study plan/protocol, MED Institute procedures, applicable regulations and signed investigator agreements in order to meet global clinical study objectives.

Responsibilities

  • Remotely monitor studies by sending queries, processing responses and ensuring that the dataset remains complete and accurate;
  • Identify and report to project leader any issues which may need attention at a particular investigative site; support resolution as needed;
  • Ensure that data are entered into the appropriate database and any issues identified are promptly resolved;
  • Travel to investigative sites to perform site initiation, periodic and closeout visits as necessary, which may include, training, assessment of adherence with the study plan/protocol and applicable regulations, and general support and training of the physician and his/her research staff;
  • Generate detailed and timely site visit reports as needed following each visit;
  • Assist in the development and/or peer review of study plans/protocols, data collection forms, patient summaries, submissions to regulatory authorities, and other study-related documentation as needed;
  • Compile and distribute the investigator file and brochure;
  • Track IRB/Ethics Committee approval and renewals; prepare and respond to IRB/Ethics Committee submissions or correspondence;
  • Track and archive essential documentation, such as insurance, agreements, CVs, etc.;
  • Assist in checking device accountability, as appropriate;
  • Work closely with both the project leader and clinical team to determine priorities and ensure that project objectives are met;
  • Establish trusted relationships with physicians, their research staff, the project team and study sponsors through communication and a commitment to exceeding expectations.
  • Communicate information and study requirements to investigators or site personnel on an ongoing basis; and
  • Complete relevant ad-hoc tasks, as assigned.

Qualifications

  • BA/BS, preferably in a life science, nursing, pharmacy related field, or similar experience within science, health care or quality;
  • Knowledge of applicable  international standards and other regulatory requirements that   may impact clinical studies is preferred;
  • Conscientious, influential person with an outstanding work ethic and strong personal discipline;
  • Willingness and capability to handle multiple projects and responsibilities;
  • Excellent organizational and problem-solving skills;
  • Excellent written, listening, and verbal communication skills; and
  • Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues.
  • Willing and able to travel, if 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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