Mobile Unit Clinical Research Coordinator (AD Psychosis)

Job Purpose/Summary:

The Mobile Unit Clinical Research Coordinator (MRU Coordinator) will support a Phase II clinical trial specific to Alzheimer’s disease (AD) Psychosis. This role will support procedures and assessments specific to the study and will help to identify Assisted Living Facilities, healthcare clinics and providers for potential referrals.  Please note that employment is contingent upon project funding and timeline requirements.

Responsibilities and Primary Objectives:

The MRU Coordinator will support the conduct of a Phase II clinical trial evaluating treatment for Alzheimer’s Disease (AD) Psychosis. This role combines clinical research, community engagement, participant recruitment, and MRU operations. 

The MRU Coordinator will conduct study visits and participant-related activities aboard a 28-foot Class C RV Mobile Research Unit, traveling throughout the Naples and greater Collier County, Florida area to Assisted Living Facilities (ALFs), healthcare providers, community organizations, and other designated locations. The MRU Coordinator will work closely with the assigned research site and GAP staff (i.e., GPS Liaison and/or Community Connector) to increase awareness of AD Psychosis, expand access to clinical research, and develop referral and recruitment opportunities.

The successful candidate will be comfortable working independently in community-based settings, interacting with older adults and their caregivers, building relationships with healthcare and community partners, performing clinical research procedures, and safely operating and maintaining a mobile clinical research environment.

Clinical Research & Participant Care

• Support the implementation of an assigned clinical research protocol in accordance with the protocol, Good Clinical Practice (GCP), applicable regulations, and organizational policies and procedures.
• Conduct study visits and protocol-required assessments on the Mobile Research Unit and, when appropriate, at designated community or healthcare locations.
• Recruit, educate, and prescreen potential study participants through community outreach, educational presentations, healthcare provider referrals, Assisted Living Facility partnerships, and other approved recruitment activities.
• Register potential participants for prescreening and provide accurate, study-related information in accordance with approved recruitment materials and procedures.
• Obtain informed consent when delegated and appropriately trained, ensuring that participants and/or legally authorized representatives understand the study requirements and have an opportunity to ask questions.
• Conduct protocol-required clinical and research procedures, which may include obtaining medical histories, performing systems reviews, collecting vital signs, conducting cognitive assessments, and completing other assessments as delegated.
• Perform phlebotomy and specimen collection in accordance with protocol, laboratory manuals, and applicable standards.
• Prepare phlebotomy supplies and kits; collect, process, label, store, and ship specimens according to established procedures.
• Verify participant identity and ensure accurate completion of specimen labels, requisitions, and associated documentation.
• Recognize abnormal or unexpected findings and escalate concerns to the appropriate clinical or research personnel in accordance with protocol and organizational procedures.
• Maintain accurate, complete, and timely source documentation, study records, and electronic data capture (EDC) entries.
• Ensure consistent execution of protocol requirements and adherence to quality control and quality assurance procedures.
• Maintain participant confidentiality and comply with applicable privacy and data protection requirements.

Mobile Research Unit Operations

• Complete required training for the safe operation and driving of the Mobile Research Unit.
• Safely operate and drive a 28-foot Class C RV throughout the Naples and Collier County area and to other designated locations as needed.
• Transport the MRU to Assisted Living Facilities, healthcare providers, community events, and other approved locations.
• Conduct pre-trip and post-trip inspections and report vehicle safety, mechanical, or operational concerns promptly.
• Maintain the MRU in a clean, organized, secure, and professional condition consistent with clinical, infection-control, safety, and regulatory requirements.
• Coordinate routine vehicle maintenance, inspections, repairs, registration renewals, preventive maintenance, and other operational requirements.
• Assist with the setup, operation, and breakdown of the MRU for study visits, participant screening activities, community outreach events, and educational programs.
• Monitor and maintain inventory of medical supplies, laboratory supplies, educational materials, office supplies, and operational equipment to ensure the MRU remains fully stocked.
• Oversee the readiness, proper storage, security, maintenance, and calibration of clinical, laboratory, and research equipment.
• Troubleshoot equipment and operational issues within the scope of training and promptly escalate issues requiring additional support.
• Maintain appropriate operational records, permits, certifications, inspection documentation, and other required compliance records.
• Ensure proper handling and disposal of biomedical waste and other materials in accordance with applicable safety, environmental, and regulatory requirements.
• Serve as the primary point of coordination for MRU operational readiness, including vehicle safety, equipment functionality, inventory, supplies, and compliance with organizational procedures.

Regulatory & Administrative Responsibilities

• Prepare and maintain required regulatory and study documentation, including IRB submissions, informed consent documentation, sponsor correspondence, delegation and training records, and other essential documents, as assigned.
• Maintain accurate and timely study files and documentation in accordance with applicable regulatory requirements and organizational procedures.
• Complete required study, safety, GCP, equipment, and MRU training.
• Communicate effectively with the assigned research site, study team, community partners, healthcare providers, and other stakeholders.
• Protect confidential participant and study information at all times.
• Perform other duties as assigned.

Preferred Education & Experience

Candidates should have education and/or clinical experience appropriate to the scope of delegated clinical research responsibilities. Preferred backgrounds include:

• Doctoral-level: MD, DO, PsyD in Clinical Psychology, PhD in Clinical Psychology, PhD in Social Work with LCSW, PhD in a medically related field, or internationally equivalent education; or,
• Master’s-level: APRN, NP, PA, Master’s degree in Clinical Psychology, Social Work with LCSW, or another clinically or medically related field; LPC preferred; or
• Nursing/Clinical: RN or bachelor’s degree (BS or BA) in a relevant clinical, healthcare, behavioral science, social science, or medically related field, or internationally equivalent education.
• Prior experience in clinical research, clinical care, behavioral health, geriatrics, neurology, psychiatry, Alzheimer's disease, or related fields required.
• Clinical research experience, including experience with participant recruitment, informed consent, source documentation, EDC systems, and protocol-required assessments, preferred.
• National phlebotomy certification through an approved certifying organization preferred; candidates without certification must be willing and qualified to obtain certification if required.
• Demonstrated ability to independently identify problems, evaluate options, and make sound decisions within established guidelines.
• Experience conducting community outreach, educational presentations, healthcare-provider engagement, or participant recruitment preferred.
• Experience working with older adults, caregivers, Assisted Living Facilities, healthcare practices, or community-based organizations preferred.

Required Skills & Competencies

• Strong interpersonal, verbal, and written communication skills.
• Ability to establish rapport and build trusted relationships with participants, caregivers, healthcare providers, Assisted Living Facility staff, and community partners.
• Strong organizational skills and attention to detail.
• Ability to work independently and manage competing priorities in a mobile/community-based environment.
• Ability to adapt to changing schedules, locations, and study requirements.
• Professional demeanor and ability to represent the organization effectively in community and healthcare settings.
• Strong problem-solving and decision-making skills.
• Ability to maintain accurate documentation and meet study timelines.
• Ability to handle confidential and sensitive information appropriately.
• Comfortable speaking to small and large groups and conducting educational presentations.
• Ability to work effectively as part of a multidisciplinary clinical research team.

Technical Skills

• Proficiency with Microsoft Office, including Word and Excel.
• Experience with electronic data capture (EDC) systems and electronic study documentation.
• Ability to learn and operate clinical, laboratory, and research equipment.
• Ability to safely operate a 28-foot Class C RV Mobile Research Unit following required training and organizational procedures.

Language Skills

• Ability to communicate effectively with participants, caregivers, healthcare providers, and community partners in English is required.
• Bilingual English/Spanish desirable.

Travel & Work Environment

• This is a mobile, community-based position requiring regular travel throughout Naples and Collier County, Florida.
• Travel within the assigned geographic region may comprise up to 75% of working time per month, with occasional short-notice travel.
• The position requires regular operation of a 28-foot Class C RV and the ability to work in an MRU, Assisted Living Facilities, healthcare practices, community settings, and outdoor event environments.
• Schedule may vary based on participant appointments, community events, healthcare-provider availability, and study requirements.
• Occasional early morning, evening, or weekend activities may be required to support recruitment events and community outreach initiatives.