Clinical Research Expert

3 days ago

Maitland, New South Wales, Australia beBeeResearch Full time $80,000 - $105,000

At K2 Medical Research, we specialize in conducting multiphasic clinical trials that promote the development of innovative and effective medical treatments while maintaining the safety and privacy of our participants.

We are committed to fighting the diseases that plague our loved ones and ourselves. By harnessing the power of advanced clinical research and connecting our patients with the treatments of tomorrow, we can improve the health of our local communities, and by extent, the population of our world.

K2 is seeking a Clinical Research Coordinator / Project Manager to support our Maitland clinic. We're looking for individuals who can manage clinical trials, ensure studies follow federal regulations and K2's guidelines (SOPs), and handle all necessary documentation for subject enrollment and maintenance.

Primary Responsibilities:
  • Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator
  • Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate
  • Communicate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator
  • Articulate all pertinent issues to the PI or document by email/letter or during meetings
  • Collect initial psychiatric and medical information by interviewing patients and accessing other appropriate sources
  • Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitors, Auditors, and any marketing groups hired by the Sponsor
  • Utilize various psychiatric rating scales and maintain interrater reliability with other clinicians at K2 Medical Research
  • Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging
  • Maintain timely K2 Medical Research source documentation as well as sponsor-required information
  • Dispense and maintain accurate records of study medication
  • Educate patients and family regarding their particular study and clinical drug trials in general
  • Complete all monitor and sponsor queries in a timely manner
  • Provide appropriate community resource referrals to patients, caretakers, and family at the conclusion of the patient's participation in the study
Knowledge, Skills, and Abilities:
  • Outstanding verbal and written communication skills
  • Excellent interpersonal and customer service skills
  • Strong time management and organizational skills
  • In-depth knowledge of industry regulations
  • Proven ability to foster mentoring relationships
  • Ability to create momentum and foster organizational change

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