Position Summary This full time position will support a multi-site research project that is responsible for the enrollment and ongoing follow-up of pregnant women who quit smoking cigarettes during pregnancy and are motivated to remain abstinent postpartum. This position will work independently, following Standard Operating Procedures and regulatory guidance to oversee all aspects of this clinical trial.
Job Responsibilities Conduct Clinic Visits, Recruitment, Data Collection, Management and Monitoring (60%) • This position will be responsible for the management and oversight of the data being collected at the lead site for a multi-center clinical trial. • Communicate effectively with the study staff on a regular basis regarding recruitment, scheduling, and assessment progress and any or all issues related to job responsibilities. • Conduct medical interviews • Complete required ethics training for research with human subjects, as well as biospecimen collection and safety training. • Develop and oversee timelines for project deliverables over the project’s life cycle • Compile and send final data sets to project bio-statisticians • Conduct telephone recruitment and screening calls • Develop rapport with participants ensure a positive research experience • Draft correspondence and send participant emails and/or mailing packets • Schedule, update, and cancel appointments using multiple online calendar systems • Organize and track study files (electronically and by paper) including participant appointment information and calling log. • Obtain informed consent from participants in compliance with ethical and regulatory guidelines. • Provide direction and guidance to participants in completing computerized questionnaires using REDCap. • Ensure protocol compliance and quality for the collection, labeling and management of biospecimen samples (blood and urine). • Collect vital signs, according to protocol guidelines • Use computer software programs including Microsoft Office and REDCap to organize, enter and manage data. • Perform quality data checks. • Ensure protection and storage of data and participant information on secure servers. • Data collection will occur at participants homes or other locations in the metro area. Travel up to 20% of the time for data collection activities.
Administrative (40%) • Perform periodic literature reviews. • Contribute to the development and dissemination of abstracts and manuscripts • This position may be asked to mentor students and interns helping to develop abstracts and supervise their time shadowing in the research clinic • Ensure regulatory compliance (Code of Federal Regulations and Good Clinical Practice) is followed • Independently develop standard operating procedures (SOPs) for study data collection. • Prepare reports and oversee project budget / expenditures as delegated by project PI • This position will be responsible for the preparation of report for the study team, monitors, funding agencies and other stakeholders. • This position will manage all aspects of the IRB • Purchasing and managing advertising for the study • Coordinate advertising efforts using online and mass media tools. And work with local clinics and community partners to advertises in these locations.
The University of Minnesota offers a comprehensive benefits package including: • Competitive wages, paid holidays, vacation and sick leave • Low cost medical, dental, and pharmacy plans • Health care and dependent daycare flexible spending accounts • Excellent retirement plans with employer match • Disability and employer paid life insurance • Wellbeing program with reduced insurance premiums • Tuition reimbursement opportunities covering 75%-100% of eligible tuition • Student loan forgiveness opportunity • Opportunities for growth and promotion • Employee Assistance Program For more information regarding benefits: https://humanresources.umn.edu/sites/humanresources.umn.edu/files/2021_tcd-cslr-75100-ben-0105-7_final.pdf
All required qualifications must be documented on application materials.
Qualifications • Bachelor's degree with at least 2 years of experience coordinating clinical research, or a combination of related education and work experience to equal 6 years. • Ability to work independently, make decisions, and problem solve. • Prior experience writing scientific reports, abstracts or manuscripts. • Demonstrated organizational and prioritizing skills. • A valid driver’s license and reliable transportation with the ability to travel in the Twin Cities area for data collection. • Must have experience with phlebotomy, injections or a willingness to be trained. • Knowledge of Good Clinical Practice and the Code of Federal Regulations
Preferred Qualifications • Experience collecting and processing biological samples • Experience with REDCap
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.