Clinical Research Coordinator
3 weeks ago
- 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, Alzheimer’s 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.
- Bachelor’s 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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