Clinical Research Coordinator

2 weeks ago

Orange, United States Pacific Neuropsychiatric Specialists Inc Full time
Job DescriptionJob DescriptionBenefits:
  • Dental insurance
  • Health insurance
  • Paid time off


PNS Clinical Research


PNS Clinical Research (PNSCR) is the research division of Pacific Neuropsychiatric Specialists, a psychiatry private practice spanning 6 locations and 40+ providers. PNSCR conducts phase II-IV psychiatry trials ranging from MDD, Schizophrenia, Alzheimers Disease, and Bipolar Disorder.


Primary Work Location: Orange, CA; occasional travel to study conferences


Primary Responsibilities and Duties include but are not limited to:


  • Assist PI, physicians, and clinical staff in patient identification, recruitment, and enrollment strategies.
  • Ensure patient enrollment and research activities comply with established protocols, regulatory and monitoring agency standards, and sponsor guidelines.
  • Screen potential patients for protocol eligibility.
  • Present trial concepts and details to patients, participate in the informed consent process and enroll/randomize patients into the study.
  • Conduct clinical trial visits, including screening and follow-up, and track participant data per protocol requirements.
  • Complete accurate and concise documentation of all participant records and other source documentation and forms per protocol.
  • Review patient charts for changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study drug, and thoroughly document all findings.
  • Attend site initiation visits and lead routine monitoring visits
  • Perform basic lab duties including the processing of samples, centrifuging, storing, and shipping of study specimens.
  • Schedule patient screening appointments, treatments, and laboratory assessments required by the protocol.
  • Prepare study data for progress reports, analysis, and meeting presentations.
  • Participate in required clinical research education and training programs.
  • Attend and represent the site at study-related investigator conferences
  • Show initiative to identify and implement ways to improve job workflow and surroundings.
  • Plan work in a manner that allows timely completion of all assignments and tasks.

Qualifications:


  • Bachelors Degree in a health-related discipline (i.e. pharmacology, nursing, biology, etc.), or equivalent experience
  • 1-3 years of clinical research experience
  • Current CPR/Basic Life Support (BLS) certification (upon hire)
  • Understanding of Good Clinical Practice (GCP) and federal regulatory standards relating to clinical research and human subject research as defined by ICH, FDA, and NIH
  • Ability to coordinate/prioritize work schedule, subject enrollment, PI's time, and multiple clinical trials concurrently
  • Ability to assess, monitor, and respond to emergency situations
  • Familiarity with medical terminology and research concepts
  • Knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, etc.
  • Interpersonal skills to work with patients, their families/ guardians, physicians, administrators, work colleagues, representatives from sponsors and others

Compensation and Benefits:


  • PNS offers a competitive compensation package including;
  • Medical, dental, and paid time off.
  • Salary based on skill, experience and tenure of your profession.

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