This entry-level research assistant position will support the Discovery Program project within the CoTIPP Lab, including the two main protocols that fall under the Discovery Program as well as other related efforts. The Discovery Program study seeks to advance measurement-based care methods by researching what self-report, behavioral, cognitive, and brain functioning measures may help predict and inform clinical progress. This ambitious study also seeks to deliver a precise, personalized, longitudinal evaluation to each individual study participant that can inform decision-making in treatment approaches. The incumbent must be able to work independently and have excellent organizational and interpersonal skills.
We are looking for a motivated individual with excellent communication and organization skills to take on the responsibilities of this groundbreaking effort. Most aspects of the study are currently conducted remotely, with plans to return to in-person study appointments when circumstances allow. 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 project described above, they may also be requested to support other research initiatives within the CoTIPP Lab or with our colleagues. Up to 30% of the incumbent’s effort may be delegated to other projects, as needed; however, the basic job description will not differ significantly from the roles and responsibilities described above.
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, JIRA, COMPAS, 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.
-Coordinate with CTSI Regulatory Monitor to prepare for monitoring visits. Respond to findings in a timely manner to resolve open findings. Submit monitoring reports to the HRPP QA system in a timely fashion. Maintain records of monitoring visits.
-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.
This position will serve as the lead study coordinator for the Discovery Program studies, performing research-related activities with that study and across the Vinogradov lab.
All required qualifications must be documented on application materials
Required Qualifications (used to screen centrally): -BA/BS or a combination of related education and employment experience totaling four years
-BA/BS in Psychology, Neuroscience, or related filed
-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
Internal Number: 340774
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