Clinical Research Coordinator

Pacific Neuropsychiatric Specialists Inc•Orange, CA

21h

About The Position

PNS Clinical Research (PNSCR) is the research division of Pacific Neuropsychiatric Specialists, a private practice spanning 6 locations and 40+ providers. PNSCR conducts phase II-IV psychiatry trials for indications including MDD, Schizophrenia, Alzheimer's Disease, and bipolar disorder. Job Summary: Under policy direction from the Clinical Research Director, the Clinical Research Coordinator will play a crucial role in supporting clinical research activities, ensuring adherence to protocols, and contributing to the advancement of medical knowledge. The Clinical Research Coordinator is responsible for assisting in patient identification, recruitment, and enrollment strategies and performing other clinical research duties for the office. The Clinical Research Coordinator is responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.

Requirements

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)
Current Good Clinical Practice (GCP) Certification (upon hire)
Detail-oriented and meticulous in all aspects of work.
Ability to prioritize tasks, effectively manage time, and allocate resources efficiently to meet tight study deadlines.
Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative

Nice To Haves

Prior clinical research experience with neurological indications such as Alzheimer’s and Tardive Dyskinesia
Prior clinical research experience with psychological indications such as Major Depressive Disorder, Bipolar Disorder, Schizophrenia, and PTSD

Responsibilities

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, take part 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.
Accurately document study data in Case Report Forms (CRFs) and electronic databases, resolving any data queries from sponsors in a timely manner.
Review patient charts for changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study drug, and thoroughly document all findings.
Manages the storage, dispensation, and tracking of investigational products as per protocol.
Attend Site Initiation Visits, facilitate routine monitoring visits, conduct Close Out Visits, and proactively work to resolve site action items in collaboration with trial monitors. Perform basic lab duties including 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
Effectively communicate and collaborate with w/ study team, including internal and external parties, sponsors, PI, and study participants.
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.