We are now seeking a lab manager passionate about advancing knowledge in the area of translational research of mood dysregulation and depressive disorders who has completed undergraduate and preferably graduate education. The candidate should have at least BA/BS plus at least 4 years of experience or advanced degree plus 2 years of experience or a combination of related education and work experience to equal eight year working in a human clinical research lab, with at least 2 years of experience in a supervisory role, and exposure to FDA regulated Investigational Device Exemption (IDE) studies. The candidate should have an in-depth knowledge of principles and practices of research management. The candidate should have experience in administering clinical ratings. The candidate should have strong leadership and interpersonal skills, strong technical capabilities, the ability to learn rapidly-evolving new systems, strong written and oral communication skills, and strong cognitive skills in the area of decision-making, strategic thinking, analysis, problem solving and identifying creative solutions. Finally, the candidate should have a strong personal commitment to ensure that the lab operates effectively, efficiently, safely, to achieve and accelerate our mission of rapid advancement of knowledge capable of alleviating suffering of participants and families. This personal commitment should set the tone for the entire lab, providing an environment of growth, productivity and a shared sense of accomplishment and importance of the mission. This lab manager will oversee and coordinate all research-related activities conducted in the lab. The lab manager should fully understand all aspects of each study so that she or he can step in at any time as needed to ensure that studies run effectively and efficiently, without interruption. The lab manager will provide administrative management of all lab research studies; design, coordinate and execute laboratory studies; oversee compliance and safety management; recruit, hire, onboard and supervise of laboratory personnel, including staff and student volunteers; monitor quality of all data collected in our lab’s studies; oversee management of all lab databases; contribute to and oversee data analysis; and assist with grant and manuscript preparation.
Lab Management - 60%:
Coordinate activities of the study team, including providing weekly reports and facilitating progress discussions with team members.
Manage daily lab operations to ensure that all laboratory processes are carried out efficiently, on-time, within budget, and according to standard operating procedures.
Direct supervision of Research Professional positions (number of research staff team members will vary over time depending on funding). Interview, hire, onboard and train future research staff. Provide annual review appraisals to the PIs.
Oversee the onboarding and off-boarding of undergraduate and graduate volunteers (number of students varies), ensure they have the appropriate training, assign activities and oversee the quality of their work.
Supervise the setup and implementation of clinical research studies through the project life cycle.
Coach research support staff on their communication style/strategy. Model professionalism in communication style.
Oversee study coordination and protocol compliance for active and completed studies.
Oversee processes related to subject recruitment and screening, informed consent, and compliance with research protocols and adherence to project timelines.
Ensure that all research activities are conducted in compliance with institutional and department policies and under strict adherence to the Federal Code of Regulations and Good Clinical Practice (GCP) Standards.
Navigate complex project approvals through regulatory oversight and compliance organizations.
Oversee the data management practices, data collection, data entry, and appropriate data storage for associated projects are managed in compliance with institutional and department policies and under strict adherence to the Federal Code of Regulations and GCP Standards.
Support research staff in handling and coordinating team efforts in the event of challenging situations such as child abuse reporting and detection of suicide risk. This will include ongoing consultation around patient confidentiality, compliance with HIPAA regulations, reporting requirements and understanding of our obligations to participants to protect their safety
Assist the PIs with the translation of study design into manualized protocols.
Manage all aspects of new and existing grants, including personnel, compliance and reporting.
Assist in grant preparation, submission and follow-up of new proposals.
Manage pre- and post-award grant activities.
Assist the PIs with FDA IDE submissions and annual reporting, IRB submissions, renewals, and modifications.
Assist the PIs in establishing Data Safety Monitoring Board (DSMB) committees for studies requiring this level of oversight; coordinate DSMB meetings and prepare DSMB reports.
Establish pricing for procedures, maintain contracts with vendors and supply orders, and manage reimbursement, petty cash and participant payment.
Foster strong relationships with study partners, in order to establish procedures for study recruitment, assessments and data acquisition.
Ensure lab adherence to federal, state, University and departmental policies and procedures
Inform PIs and co-investigators of adverse events, assist the PI in reporting Serious Adverse Events to local IRB and national Data Safety Monitoring boards
Assist PIs with creating materials for research presentations, grants and manuscripts.
Resolve administrative problems as they arise
Establish and oversee the use of offices, furniture and equipment for study staff, including the allocation of space and coordination of office/lab assignments
Monitor quality of data collection, storage and management
Manage and maintain detailed records of work performed
Incorporate common project management technology for team members to improve communication and assist in meeting all stated deadlines
Utilize participant visit tracking system using study database tools
Evaluate expenditure of research funds, and prepare yearly reports and budgets.
Direct execution of study activities - 0-40%: The Lab Manager should be intimately familiar with the all study procedures for each of the studies in the lab so that he or she can appropriately oversee the correct implementation of study procedures and also step in as needed when core study staff are away and not able to complete study tasks. These would include administering clinical ratings and questionnaires, collection of data, completion of CRF’s and basic statistical analyses.
The PI may assign special tasks and collaborations with other faculty based on research exploration interests and funding availability or coverage.
To apply for this position please visit: https://hr.myu.umn.edu/jobs/ext/340180
Internal Number: 340180
About University of Minnesota Medical School
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.