Clinical Trials Professional

10 hours ago

Maitland, New South Wales, Australia beBeeResearch Full time $70,000 - $95,000
Job Title

Clinical Research Coordinator / Project Manager Role Summary:

We are seeking a highly organized and detail-oriented individual to support our research endeavors. The successful candidate will be responsible for managing clinical trials, ensuring studies adhere to federal regulations and company guidelines, and handling all necessary documentation for subject enrollment and maintenance.

About the Role

This Clinical Research Coordinator / Project Manager position involves understanding thoroughly assigned studies through reading protocols, attending investigator meetings, and coordinating with the Principal Investigator.

  • Ensure adherence to study protocol; obtain exemptions when necessary/appropriate.
  • Communicate protocol issues to relevant stakeholders.

The ideal candidate will have excellent communication skills, a strong working knowledge of GCP and FDA guidelines, and experience in a clinical environment.

A Bachelor's degree is strongly preferred, but not required. Relevant certifications and training can also be considered.

Key Responsibilities
  1. Understand thoroughly all assigned studies through reading protocols, attending investigator meetings, and coordinating with the Principal Investigator.
  2. Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate.
  3. Communicate protocol issues to the CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator.
  4. Collect initial psychiatric and medical information by interviewing patients and accessing other appropriate sources.
  5. 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.
  6. Utilize various psychiatric rating scales and maintain interrater reliability with other clinicians at K2 Medical Research.
  7. Perform clinical tasks including vital signs, height and weight, ECG, phlebotomy, specimen packaging.
  8. Maintain timely source documentation as well as sponsor-required information.
  9. Dispense and maintain accurate records of study medication.
  10. Educate patients and family regarding their particular study and clinical drug trials in general.
  11. Complete all monitor and sponsor queries in a timely manner.
  12. Provide appropriate community resource referrals to patients, caretakers, and family at the conclusion of the patient's participation in the study.
Requirements
  • HS Diploma or GED required; Bachelor's degree strongly preferred.
  • Two years of experience in a clinical environment; experience in clinical research is ideal.
  • LPN, RN, or other medical licensure or certification.
  • Strong working knowledge of GCP and FDA guidelines.
  • Knowledge of medical terminology.
  • BLS Healthcare Provider certification required.
  • Bilingual in Spanish and English strongly preferred.
  • Applicants with related education and applicable experience may be considered upon approval.

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