Senior Clinical Trials Research Coordinator

About the Role

This 100% position is for the Senior Clinical Research Program Coordinator of the Innovating in Mood and Substance Use Disorders Personalized and Accelerated CNS Therapeutics (IMPACT) Lab and Mood Disorders Research Program directed by Dr. Manpreet Singh at the UC Davis Medical Center.

The IMPACT Lab conducts clinical and translational research related to neurobiological markers of major mood disorders and their treatments in children, adolescents, and young adults. Research involves longitudinal clinical, cognitive, behavioral, EEG, and MRI assessments, as well as preclinical and clinical assays aimed to investigate neurodevelopmental mechanisms and risk and resilience factors for lifelong mood disorders. The lab aims to intervene as early as possible to prevent the development of disease-related deficits and treatment-related side effects for youth with mood and related disorders.

The incumbent will support the Principal Investigator (PI) in the development and execution of clinical trials and other research projects, including contributing advanced knowledge to project development and execution. Responsibilities include independently managing participant recruitment and eligibility determinations, study conduct, data collection and organization, and using advanced statistical analysis skills to lead data analysis and support the development of manuscripts, grants, or other research-related products.

Responsibilities

• Coordinate and manage clinical research studies within the Department of Psychiatry, ensuring compliance with study protocols, Good Clinical Practice (GCP), federal and state regulations, and institutional policies.
• Provide leadership and oversight for clinical research activities, including study start-up, participant recruitment and retention, study visits, data collection, regulatory compliance, and study close-out.
• Oversee multiple clinical trials simultaneously and provide guidance, training, and mentorship to clinical research coordinators and other research staff.
• Independently manage IRB protocols, communications with various stakeholders, and ensure compliance with requirements.
• Support budget development and management across clinical and research programs, including budgets for federally funded projects.
• Support community engagement or fundraising activities.
• Utilize independent judgment to prioritize tasks, respond to program needs, and adjust priorities as required.
• Perform advanced statistical analysis (e.g., descriptive statistics, T-tests, ANOVA, regression) and prepare data for Data Safety Monitoring Board review.
• Manage administrative support for hiring, onboarding, and required evaluations of staff.
• Measure and record vital signs and anthropometric measurements, and process blood and serum samples.
• Create study source documents and work with sponsor-related applications/tools.
• Prepare study budgets and facilitate budget negotiations.
• Demonstrate leadership in data management and oversight responsibilities.

Breakdown of Responsibilities:

• 70% - Research Coordination and Management
• 10% - Data and Compliance Management
• 10% - IRB Management for Multiple Projects
• 5% - Oversight and Mentoring Junior Research Coordinators
• 5% - Budget and Research Billing Review

Requirements

• Bachelor's degree in a related field such as psychology, neuroscience, health science, nursing, public health, or a related discipline.
• Minimum of three years of experience coordinating and conducting multiple clinical trials in psychiatry, behavioral health, neuroscience, or a related field.
• Certification as a Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent (preferred).
• Experience coordinating industry-sponsored, investigator-initiated, or federally funded clinical trials.
• Experience with psychiatric clinical trials involving medications, psychotherapy, digital therapeutics, or other behavioral health interventions.
• Experience working with vulnerable populations or individuals with psychiatric diagnoses, particularly children and adolescents.
• Experience with electronic data capture systems, clinical research databases, and statistical software (e.g., SPSS).
• Experience with regulatory submissions, sponsor monitoring visits, GCP, IRB requirements, and informed consent processes.
• Experience with Microsoft Suite, web-based electronic data capture platforms, bibliographical applications (e.g., Zotero or Mendeley), and statistical software.
• Experience developing, overseeing, and managing IRB protocols and documents.
• Direct experience and oversight responsibilities in data management.
• Experience preparing study budgets and facilitating budget negotiations.
• Demonstrated experience working with children and adolescents, including those with autism.
• Advanced knowledge of FDA regulations related to the conduct of research.
• Strong organizational skills to handle multiple tasks simultaneously and meet deadlines.
• Excellent written and verbal communication skills, including the ability to convey factual information to investigators and engage in collaborative problem-solving.
• Analytical skills to evaluate information, practices, and procedures, and formulate logical conclusions.
• Advanced-level knowledge of psychiatric populations, basic neuroanatomy, medical terminology, and ability to interpret physicians' notes, medical records, laboratory, and scan results.
• Mathematical skills to perform calculations involving basic accounting, body mass index (BMI), and drug dosing and compliance calculations.
• Demonstrated knowledge of safe laboratory practices, including processing blood and serum samples and preparing laboratory slides.
• Proven ability to collect, check, and analyze data, and create lists and reports.
• Ability to work effectively with multidisciplinary teams and external research partners.
• Demonstrated leadership and interpersonal skills to train and mentor less experienced staff.
• Ability to work independently, exercise judgment, and solve problems proactively.

Preferred Qualifications

• Graduate-level degree (Master's or Ph.D.) in neuroscience, psychology, public health, clinical research, nursing, or a related field.
• Understanding of psychiatric conditions according to DSM-5.

Pay

$43.69–$70.25 per hour.

Schedule

Full-time (100%), Monday–Friday, 8:00 AM–5:00 PM.

Benefits

Outstanding benefits and perks are among the many rewards of working for the University of California. UC Davis offers a full range of benefits, resources, and programs to help employees achieve their health, wellness, financial, and career goals. For more details, visit the UCnet Benefits Page or the Benefits Summary for UC Davis Health Employees.