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Arise Psychiatric Medical Group, Inc.

Clinical Research Coordinator II

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What they do

A Clinical Research Coordinator directs clinical research and development projects for companies, and coordinates testing and quality control.

$135,054 / year median in California

+16% projected growth

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Job Description

Clinical Research Coordinator II Arise Psychiatric Medical Group, Inc. Bakersfield, CA Job Details Full-time $60,000 - $65,000 a year Benefits Health insurance Dental insurance 401(k) Vision insurance Qualifications Healthcare incident report preparation Informed consent Adverse event reporting HIPAA Research project coordination ICH guidelines Bachelor's degree Informed consent procedures implementation Health information regulatory compliance Research compliance clinical trial records management Patient recruitment Managing patient records Technical Proficiency FDA regulations Research compliance quality assurance records management Full Job Description Job Summary We are seeking a highly motivated and detail-oriented Transcranial Magnetic Stimulation (TMS) Research Coordinator to support innovative neuromodulation clinical research studies. This position is responsible for coordinating and conducting TMS-based clinical trials while ensuring participant safety, protocol adherence, regulatory compliance, and high-quality data collection. The TMS Research Coordinator will work closely with Principal Investigators, sponsors, neuroscientists, study participants, and multidisciplinary research teams to administer study treatments, coordinate participant visits, maintain regulatory documentation, and support all aspects of clinical trial operations. The ideal candidate has experience with clinical research and an interest or background in neuroscience, psychiatry, or neuromodulation technologies. Essential ResponsibilitiesTMS Treatment Administration & Technical Operations Administer Transcranial Magnetic Stimulation (TMS) treatments in accordance with study protocols and physician direction. Position treatment coils accurately and operate TMS hardware and software according to protocol specifications. Perform motor threshold (MT) determinations under investigator supervision to establish appropriate treatment intensity. Verify treatment parameters prior to each session and document all treatment activities. Troubleshoot equipment issues and coordinate preventive maintenance and calibration activities. Support studies utilizing additional modalities such as EEG, fMRI, or computerized behavioral assessments when required. Clinical Trial Coordination Coordinate participant visits from screening through study completion. Recruit and screen potential participants using protocol-specific inclusion and exclusion criteria. Conduct informed consent discussions in accordance with ICH-GCP and institutional requirements. Schedule treatment sessions and follow-up visits while maintaining protocol compliance. Perform protocol-required clinical assessments, questionnaires, cognitive testing, vital signs, and study procedures. Maintain participant engagement to promote retention and protocol adherence. Patient Safety & Adverse Event Monitoring Continuously monitor participants during TMS treatment sessions. Assess participant tolerance and identify potential adverse events including headache, scalp discomfort, dizziness, syncope, or seizure activity. Document adverse events (AEs) and serious adverse events (SAEs) according to protocol and regulatory requirements. Immediately notify the Principal Investigator or designated medical provider of any safety concerns or protocol-defined reportable events. Maintain emergency preparedness and ensure adherence to established TMS safety guidelines. Regulatory Compliance & Data Management Maintain accurate source documentation and study records. Enter study data into Electronic Data Capture (EDC) systems and study databases. Resolve sponsor and monitor data queries in a timely manner. Maintain regulatory binders, Investigator Site Files (ISF), and essential study documentation. Assist with Institutional Review Board (IRB) submissions, continuing reviews, protocol amendments, and regulatory correspondence. Prepare studies for sponsor monitoring visits, audits, and regulatory inspections. Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and Human Subjects Protection regulations. Administrative & Research Support Serve as a liaison among investigators, sponsors, Contract Research Organizations (CROs), participants, and research staff. Maintain study equipment and supply inventories, including TMS consumables and treatment accessories. Coordinate laboratory specimens or ancillary testing when required. Assist investigators with data review, quality assurance activities, abstracts, presentations, and manuscript preparation. Participate in investigator meetings, sponsor trainings, and protocol implementation activities. Required QualificationsEducation Bachelor's degree in Neuroscience, Psychology, Biology, Nursing, Biomedical Engineering, Health Sciences, Public Health, or a related field. Equivalent clinical research experience may be considered. Experience Two or more years of experience coordinating clinical research studies. Experience working with industry-sponsored or investigator-initiated clinical trials. Experience in neurology, psychiatry, neuroscience, or behavioral health research preferred. Experience working directly with Principal Investigators, sponsors, CROs, and study monitors. Clinical Research Knowledge Working knowledge of: International Council for Harmonisation - Good Clinical Practice (ICH-GCP) FDA regulations governing clinical research Human Subjects Protection requirements HIPAA regulations Experience with: Participant recruitment and retention Informed consent Study coordination Source documentation Electronic Data Capture (EDC) Regulatory documentation Adverse event reporting Sponsor monitoring visits Technical Skills Experience with one or more of the following: Transcranial Magnetic Stimulation (TMS) systems Electronic Data Capture (EDC) platforms REDCap Medidata Rave Epic or other Electronic Medical Record (EMR) systems Microsoft Office Suite EEG, fMRI, or other neurodiagnostic technologies (preferred) Preferred Qualifications Experience coordinating neuromodulation clinical trials. Experience with psychiatric or neurological disorders, including Major Depressive Disorder (MDD), Bipolar Disorder, Schizophrenia, Obsessive-Compulsive Disorder (OCD), PTSD, Anxiety Disorders, stroke rehabilitation, or other Central Nervous System (CNS) conditions. Familiarity with TMS safety screening procedures and treatment guidelines. Experience administering or supporting standardized psychiatric and cognitive rating scales. Experience with Institutional Review Board (IRB) submissions, FDA Form 1572, protocol amendments, and Investigator Site Files (ISF). Knowledge of EEG, fMRI, neuroimaging, or other neuroscience research methodologies. Preferred Certifications Certified Clinical Research Coordinator (CCRC) Certified Clinical Research Professional (CCRP) Good Clinical Practice (GCP) Certification CITI Human Subjects Protection Certification TMS device-specific certification or manufacturer training (preferred) What We're Looking For The ideal candidate is technically proficient, detail-oriented, and committed to advancing neuroscience research through exceptional clinical trial coordination. Success in this role requires strong organizational skills, excellent communication, sound clinical judgment, and the ability to maintain participant safety while delivering complex neuromodulation protocols with precision.
Pay:
$60,000.00 - $65,000.00 per year
Benefits:
401(k) Dental insurance Health insurance Vision insurance
Location:
Bakersfield, CA 93311 (Preferred) Ability to
Commute:
Bakersfield, CA 93311 (Preferred) Ability to
Relocate:
Bakersfield, CA 93311: Relocate before starting work (Preferred)
Work Location:
In person