Clinical Research Coordinator - Neuromodulation (Research Professional 2)

Dr. Ziad Nahas (Interventional Psychiatry Lab) in the Department of Psychiatry and Behavioral Sciences is seeking a full-time Clinical Research Coordinator (Professional 2) passionate about advancing knowledge in the area of translational research of mood dysregulation and depressive disorders. This is an excellent opportunity to grow a fascinating career in research while working with supportive faculty. This position will be primarily split between two focuses.

First, the candidate will focus on coordination of a trial of psilocybin combined with DBT in participants who have borderline personality disorder, including drug management and clinical care monitoring. Second, the candidate will enhance the lab's ability to collect imaging data across studies prior to intervention, particularly before implantation of PACE, VNS, or starting a course of ECT or ketamine. Successful candidates will also be cross-trained in all procedures completed by the lab for other studies, to improve study management.

This candidate will work directly with participants receiving invasive brain stimulation treatment regularly, and a successful candidate will be responsible for ensuring that trials are run in an ethical, scientifically rigorous, and timely manner, with a special emphasis on valuing kindness as it relates to self, the team and the participants who donate their time and energy to advance scientific discovery.

Please note, this position is not able to support a visa.

Job Duties/Responsibilities:

Recruitment - 15%
Responsible for patient recruitment, screening, consent, enrollment, and registrations for clinical studies in people with mood and/or substance use disorders

Specific Recruitment Duties:
*Maintain a working knowledge of patient eligibility and protocol specific requirements
*Participate in recruitment efforts for new study participants, including partnership with clinicians and community-based clinics
*Ensure that all candidates have a comprehensive understanding of study procedures
*Assist with or complete consenting/screening process for new study patients
*Collect/obtain all necessary screening samples to be sent to study sponsors
*Procure outside medical records and information as needed for study
*Complete other documentation as directed, such as database entry
*Facilitate physician review of study specific lab reports and participant assessments

Study Management - 50%
Monitor implementation, management, coordination and documentation of all study activities in accordance with GCP, federal regulations and institutional policies. Ensure that components of the project are completed in an ethically, scientifically, rigorous and timely manner. Continuously update safety records and procedures.

Specific Study Management Duties:
*Maintain working knowledge of assigned protocol
*Perform study procedures at all visits per protocol specific guidelines, managing follow up schedule
*As appropriate, complete training on clinical assessment and conduct with participants per protocol, including mental health questionnaires and cognitive assessments
*Communicate regularly with participants via phone, email and zoom via lab email address
*Complete case report forms and respond to monitor issues queries
*Complete adverse event (AE) logs and other study documentation
*Complete required forms for any serious adverse events (SAE) and report and notify appropriate departments / sponsors per requirements
*Schedule/conduct study monitor visits as directed by study sponsor
*Draft study protocol amendments as appropriate, working with regulatory specialist to submit and file
*Ensure paper or digital study logs are complete and updated
*Update participants on study amendments and complete the re-consenting process
*Communicate with principal investigator to ensure study specific procedures are completed
*Participate in new study start up and set up with upcoming sponsors and IPL staff

Data Management - 20%
Perform study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records, and personal communications with other healthcare workers; review collected data frequently for potential errors

Specific Data Management Duties:
*Maintain working knowledge of medical terminology, critical lab values, and understanding of medical conditions
*Maintain working knowledge of various sponsor specific databases and portals
*Enter patient registration and visit dates in various internal databases (Oncore and Florence) and medical chart as necessary
*Serve as the site data manager and staff contact for issues arising with data management or entry
*Prepare for monitoring visits by reviewing paper and electronic source regularly

Laboratory activities - 5%
Lab protocol set up, sample processing, packaging and send out as required per protocol. Must be able to follow standard operating procedures for select instruments and/or methods to meet requirements of the research.

Specific Laboratory Duties:
*Collecting samples from participants
*Communicating with laboratories across campus to ensure proper handling and delivering of samples, as appropriate
*Shipping to central laboratories, as appropriate
*Setting up protocol specific procedural manuals and documentation throughout study

Other Duties as Assigned - 10%
Attend and contribute to lab meetings and supervisory meetings, respond in a timely manner to inboxes (phone/email, personal/shared), participate in (and potentially present at) local and national conferences. Contribute to data analysis and publication/grant writing, as appropriate for role and experience. Attend goal setting and monitoring meetings with supervisor regularly and share professional development needs.

Required Qualifications:
*BA/BS plus at least 2 years of relevant experience or a combination of education and relevant experience to equal at least 6 years.
*Knowledge of clinical research, Good Clinical Practices (GCPs) and federal regulations related to clinical research.
*Exposure to mental health clinical care or mental health clinical research
*Exposure to FDA regulated drug and/or device clinical trials.
*Exposure with the Informed Consent Process.
*Exposure to OnCore or other CTMS software tools, including electronic databases
*Proficiency with Microsoft Office software and PC devices
*Consider kindness to clients and coworkers as a critical value in professional life
*Ability to work independently, make decisions, problem solve and prioritize tasks
*Possess excellent communication skills, verbal and written, in person, over the phone, and via brief and longer computer based messaging
*Some general experience with mentoring, training, or as a team lead

Preferred Qualifications:
*Experience with FDA regulated drug and/or device clinical trials, including FDA submission management
*Experience with REDCap Database/Form Development and project development
*Experience in mental health clinical care or research, particularly neuromodulation
*Experience with the Informed Consent Process, ideally with eConsent methods
*Experience with electronic medical records systems (e.g., Epic)

The Department of Psychiatry & Behavioral Sciences consists of an outstanding team of researchers, clinicians, and educators who provide world-class expertise in psychiatric illness, treatment, scholarship, and scientific discovery.

Our mission is to:

• Create and disseminate new knowledge in the science of mental health
• Provide effective and innovative clinical care programs to alleviate the suffering of mental illness and promote mental resilience
• Train the next generation of interprofessional experts who will be leaders in Minnesota and beyond
• Engage in compassionate and vigorous outreach and advocacy on issues relevant to psychiatric illness, treatment, and research

You can find more information on our website at https://med.umn.edu/psychiatry.

Pay Range: Salary range is $62,000 - $72,000/year depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

While our salary ranges provide a framework, it is important to note that most of the
time, the initial pay may not reach the maximum of the range. This approach ensures
that compensation reflects the value and unique contributions of each candidate while
maintaining equity within our organization. As part of our commitment to fair and
equitable compensation, please be aware that the salary offered to incoming candidates
will be based on their individual credentials and experience.

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail jobcentr@umn.edu.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

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