Clinical Research Associate
Cook Medical - West Lafayette, IN

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Clinical Research Associate

MED Institute, Inc. is currently accepting applications for a Clinical Research Associate to become a part of our growing Clinical Study Operations team. This is an in-house position where the individual 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, Cook 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 management 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 visits if 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 process and project management 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.
Essential Qualifications
  • BA/BS, preferably in a life science, nursing, pharmacy related field, or similar experience within science, healthcare 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.

Cook Medical - 7 months ago - save job - block
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Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...