Research Support - Laboratory/Non-Laboratory, Staff/Administrative
This entry-level Study Coordinator position will support the EPINET, Mini-COTES and Moodify/MMT projects within the CoTIPP Lab. These projects are clinical trials examining mobile cognitive training platforms to improve neuroplasticity and improve patient outcomes. The incumbent will recruit participants from the Psychiatry Clinics at the University of Minnesota Department of Psychiatry Outpatient Clinic and the St. Louis Park Mental Health Neuromodulation Clinic. EPINET and Mini-COTES enroll individuals aged 15-40 receiving care at first episode psychosis clinics. Moodify/MMT is a pilot study that enrolls patients with unipolar depression or anxiety, aged 18-60. These studies all include a longitudinal component with follow ups occurring at regular intervals. The incumbent must be able to work independently and have excellent organizational and interpersonal skills.
The incumbent will work closely with the staff at the recruitment site to facilitate enrollment and participant retention. This includes participant outreach and communicating with their respective care team/s. The incumbent will be responsible for the recruitment of adult and adolescent participants, scheduling and conducting study appointments, data management tasks, and regulatory documentation. The incumbent will receive training in GCP and federal regulations surrounding clinical research, data safety practices, assessing capacity to consent and conducting informed consent, and regulatory management and documentation. Training for specialized equipment will be provided as needed.
The CoTIPP Lab is a highly collaborative environment, as evidenced by our broad interdisciplinary network of research colleagues. While the incumbent of this position will work primarily on the projects described above, they may also be requested to support other research initiatives within the CoTIPP Lab or with our colleagues. However, the basic job description will not differ significantly from the roles and responsibilities described above. The hiring manager for this position is Ariel Currie.
Duties/Responsibilities: Participant Recruitment and Retention (30%):
Recruit interested individuals to participate in research projects. Meet in person or over the phone and answer email inquiries.
Use pre-established recruitment materials to advertise in the community, per protocol.
Coordinate with clinicians at recruiting sites via email, EPIC, and in-person meetings to learn of potential participants and coordinate introductions.
Communicate with other labs to facilitate sharing of potential participant information.
Screen participants for eligibility using pre-established scripts and questionnaires.
Obtain informed consent and assent. Conduct assessments of capacity to consent to research. Re-consent participants as needed after protocol modifications. Consent participants when they reach the age of majority if they were a minor when enrolled.
Maintain regular contact with research participants (per protocol) in person, by phone, or by email to keep participants engaged in research activities.
Track participant progress through study milestones. Provide support as needed to complete study activities.
Dispense participant compensation.
Support participants with technological issues during remote components of the study.
Other tasks as assigned.
Data Collection and Management (40%):
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, iPads, digital databases, and specialized equipment, per protocol.
Conduct assessments such as: diagnostic interviews; clinical interviews for symptom and functioning; and neurocognitive assessments.
Support patients during self-report tasks, including providing instructions, technical troubleshooting, and clarifying questions.
Collect data using specialized equipment (e.g., EEG, fMRI), as needed.
Score assessment materials and complete paperwork from appointments. Verify scores of assessments from other raters.
Create and maintain databases for the projects using Box, REDCap, and other data management systems as required.
Enter scored data into databases. Verify entered data using double-entry procedures, per protocol.
Extract data from third party vendor platforms (e.g., cognitive assessment software) for permanent storage in study databases.
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.
Regulatory Management and Documentation (20%):
Adhere to local and federal policies for conducting research and documentation of study activities.
Maintain regulatory documents, such as: enrollment logs; participant visit logs; protocol deviation logs; personnel training records; recruitment/screening logs; randomization keys; device/account tracking logs; and other documentation as required.
Use University systems such as Florence, OnCore, Box, and REDCap to maintain databases for regulatory documentation.
Maintain digital copies of consent forms, obtained either through e-consent platforms, or by scanning paper copies into permanent storage.
Document study events using Notes to File, as required.
Support 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.
Coordinate with Regulatory Specialists or Project Managers for submission of modifications to IRB for review. Support responses to clarification questions or stipulations from the IRB, as required.
Implement updates to materials after protocol modifications are approved (e.g., update consent forms to the approved version).
Prepare regular updates to the Institutional Review Board, reporting agencies, and grant sponsors, as needed.
Prepare timely submissions to IRB for prompt reporting (e.g., reporting of protocol deviations due to researcher error), as needed.
Other tasks as assigned.
Lab Support Tasks (10%):
Conduct literature reviews in support of manuscripts, grants, and other tasks as needed.
Prepare materials for presentations, publications, and grants, such as figures or tables.
Participate in regular team meetings.
Assist in ordering and management of study supplies, as needed.
Prepare presentations for Journal Club, Lab Meetings, other short presentations, etc., when requested.
Other tasks as assigned.
All required qualifications must be documented on application material
BA/BS or a combination of related education and employment experience totaling four years
Previous experience conducting clinical research including: screening and recruiting participants; obtaining informed consent; conducting standardized clinical psychiatric interviews and/or neurocognitive assessments; data entry and database management; regulatory management
Previous experience working with individuals with mental health conditions such as psychosis spectrum disorders in a clinical or research setting
BA/BS in Psychology, Neuroscience, or related filed
Internal Number: 340363
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