Senior Clinical Trials Research Coordinator

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.

About the Role

The Senior Clinical Trials Coordinator is responsible for the coordination and management of clinical research studies within the Department of Psychiatry. This position works closely with principal investigators, sub-investigators, research staff, sponsors, contract research organizations (CROs), institutional review boards (IRBs), and study participants to ensure clinical trials are conducted in accordance with study protocols, Good Clinical Practice (GCP), federal and state regulations, and institutional policies.

The Senior Clinical Trials Coordinator provides 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. This role may oversee multiple clinical trials simultaneously and may provide guidance, training, and mentorship to clinical research coordinators and other research staff.

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 and 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.

Responsibilities

• Support the PI in the development and execution of clinical trials and other research projects generated by the group, including contribution of advanced knowledge to project development and execution.
• Independently manage participant recruitment and eligibility determinations.
• Manage study conduct, data collection, and organization.
• Use advanced statistical analysis skills to lead data analysis and support development of manuscripts, grants, or other research-related products.
• Independently manage multiple IRB protocols.
• Support communications with various stakeholders and ensure compliance with requirements.
• Provide administrative support for the hiring, onboarding, and required evaluations of staff.
• Support budget development and management across clinical and research programs.
• Support community engagement or fundraising activities.
• Coordinate and manage the overall administration and outcome of one or more clinical research studies.
• Provide leadership to other support personnel.
• Utilize independent judgment to prioritize tasks and respond to the needs of program staff and students.
• Plan, organize, evaluate situations, make decisions, adjust priorities, work independently, and respond flexibly to requests for assistance in problem-solving.

Key Responsibilities Breakdown:

• 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 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 (encouraged for full consideration).
• Experience coordinating multiple clinical research studies or complex clinical trials.
• Experience with budget development and management, including budgets for federally funded projects and other sources.
• Extensive experience with research recruitment and at least 2 years of experience in providing support to other clinical research staff.
• 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.
• Experience with electronic data capture systems and clinical research databases.
• Experience with regulatory submissions and sponsor monitoring visits.
• Experience with clinical research regulations, 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 measuring and recording vital signs and anthropometric measurements.
• Experience creating study source documents and working with sponsor-related applications/tools.
• Previous experience developing, overseeing, and managing IRB protocol documents.
• Direct experience and oversight responsibilities in data management.
• Demonstrated experience working with children and adolescents.
• Experience preparing study budgets and facilitating budget negotiations.
• Experience with statistical programs and preparation of data for Data Safety Monitoring Board review.
• Demonstrated experience working with children and adolescents with autism.

Skills

• Strong organizational skills and demonstrated ability to manage competing priorities and deadlines.
• Excellent written and verbal communication skills.
• Strong attention to detail and ability to maintain accurate and confidential records.
• Ability to work effectively with multidisciplinary teams and external research partners.
• Knowledgeable about recruitment and retention strategies for clinical study participants.
• Comprehensive knowledge of Good Clinical Practices, IRB regulations, elements of informed consent, and ethical principles related to the participation of human subjects in biomedical research.
• Advanced and current knowledge of FDA regulations related to the conduct of research.
• Demonstrated leadership and interpersonal skills to train and mentor less experienced staff.
• Analytical skills to evaluate information, practices, and procedures, formulate logical and objective conclusions, and make recommendations for effective solutions.
• Advanced-level knowledge of psychiatric populations, basic neuroanatomy, medical terminology, and ability to interpret physicians' notes, medical records, laboratory, and scan results.
• Excellent writing skills to compose reports and correspondence, and clearly document research data onto forms.
• Mathematical skills to perform calculations involving basic accounting, body mass index (BMI), and drug dosing and compliance calculations.
• Demonstrated knowledge of safe laboratory practices, and experience with processing blood and serum samples and preparing laboratory slides.
• Knowledge of biological, social, and psychological mechanisms related to mental health and/or cognitive functioning obtained through advanced graduate study or additional substantive training.
• Demonstrated knowledge of research principles and ethics, ability to follow protocols, and to use the internet for research.
• Proven ability collecting, checking, and analyzing data and creating lists and reports.
• Organizational skills and attention to detail in maintaining large volumes of data.
• Demonstrated ability to use word processing and other computer software to type from verbal/written instructions with speed and accuracy.
• Advanced knowledge of spreadsheet software such as Excel to perform mathematical tasks accurately, create and edit data, and create documents.
• Advanced knowledge of Microsoft applications including Microsoft Word and PowerPoint, electronic calendaring, and email software (Outlook).
• Knowledge of statistical analysis methods (e.g., descriptive statistics, T-tests, ANOVA, regression) and associated software (e.g., SPSS).
• Excellent oral and written communication skills to effectively work with physicians, consumers, families, clinical staff, research staff, and other healthcare professionals.
• Proven skill exercising discretion and using independent judgment to answer questions, respond to queries, and overcome challenges.
• Successful record of assisting co-workers and actively participating as a team member.
• Ability to establish and maintain effective interpersonal relationships in performance of duties and consistently demonstrate professional interpersonal skills.
• Proven ability to independently perform a variety of functions accurately and to work in an environment of frequent interruptions.
• Ability to organize workload and set changing priorities; identify deficiencies in operating procedures and independently create solutions; work accurately, neatly, and quickly under pressure and strict deadlines.
• Ability to independently exercise judgment, initiative, and resourcefulness in making decisions.
• Demonstrated successful performance in a high-intensity work environment.
• Ability to work well and communicate effectively with child and adolescent research subjects and their parents.

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

Salary Range: $43.69 - $70.25 per hour

Schedule

• Shift: 8 AM - 5 PM
• Percentage of Time: 100%
• This position is 100% on-site.

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 you bring your best self to work, as well as to help you and your family achieve your health, wellness, financial, and career goals.

• For more information, visit the UCnet Benefits Page or Benefits Summary for UC Davis Health Employees.