This Clinical Research Coordinator position (Research Professional 2) will work on a study team completing cutting edge research using methods such as transcranial magnetic stimulation, magnetic resonance imaging, and drug interventions. The incumbent will coordinate a randomized controlled trial investigating functional connectivity, cognitive, and clinical symptom changes in relation to the use of ketamine in a sample of veterans (18-75) with comorbid PTSD and major depressive disorder (MDD). The incumbent will work primarily independently to complete all aspects of the study with PI support. This work is supported by a K23 grant from the National Institutes of Mental Health (NIMH).
There will be opportunities to contribute to research dissemination efforts within the lab including working with and analyzing data, writing abstracts for scientific meetings, and writing manuscripts for publication in research journals.
This is a hybrid position located on-site at the Minneapolis Veteran's Administration (VA) with flexibility for remote work from home.
C. Sophia Albott, MD, MA, is the Principal Investigator of this study. She is Head of the Division of Adult Mental Health and an Assistant Professor at the University of Minnesota, Department of Psychiatry and Behavioral Sciences. She also has an appointment at the Minneapolis VA where the majority of her research is currently conducted. Additionally, she conducts clinical work at the Interventional Psychiatry Program with M Physicians.
Job Duties/Responsibilities:
The distribution of effort will change over time. As the study is currently enrolling subjects, Protocol/Regulatory/Study Management will constitute most of the effort. As recruitment goals are met, effort will shift to data analysis, manuscript preparation, grant preparation and general lab management support.
Data Collection and Study Management (50%)
*Schedule appointments with participants and assessment staff per protocols. Provide participants with instructions and materials needed to prepare for the visit. Remind participants of upcoming visits using approved communication methods.
*Prepare for study appointments per protocol by: reserving rooms and equipment; printing off forms; creating participant profiles within data capture systems; charging equipment; and other tasks as needed.
*Collect data using paper forms, computers, digital databases, and specialized equipment, per protocol.
*Conduct assessments such as: diagnostic interviews; clinical interviews for symptom and functioning; and side effect questionnaires.
*Support patients during self-report tasks, including providing instructions, technical troubleshooting, and clarifying questions.
*Complete follow-up calls to participants the day after study infusions.
*Collect data using specialized equipment (e.g., fMRI, TMS, vitals), as needed.
*Score assessment materials and complete paperwork from appointments.
*Maintain databases for the projects using Box, REDCap, and other data management systems as required.
*Complete regular quality checks and clean-up of data.
*Prepare data for submission to national data archive centers, per grant requirements.
*Prepare regular updates for lab meeting and study team meetings, as needed.
*Promptly communicate critical observations to study team leads, as required.
*Other tasks as assigned.
Participant Recruitment and retention (30%):
*Recruit interested individuals to participate in research projects
*Screen participants for eligibility using pre-established scripts and questionnaires.
*Conduct medical chart reviews for eligibility
*Provide a supportive presence throughout visits
*Dispense participant compensation.
*Obtain informed consent.
Regulatory Management and Documentation (20%)
*Maintain regulatory compliance with both University and VA IRBs
*Adhere to local and federal policies for conducting research and documentation of study activities.
*Maintain regulatory documents and all study documentation, both digital and physical.
*Document study events using Notes to File, as required.
*Support and submit protocol modifications, including: drafting updates to the protocol document; drafting changes to consent and assent forms; drafting changes to recruitment materials; and other tasks as assigned.
*Implement updates to materials after protocol modifications are approved (e.g., update consent forms to the approved version).
Performing job duties will require:
*Standing or sitting for extended periods.
*Complex communication of medical information in the English language.
*Professional interactions with a diverse body of colleagues and research participants.
*Acquisition and maintenance of all necessary requirements (e.g., background checks, immunizations, institutional trainings) for work with human subjects, including subjects from vulnerable populations.
