Clinical Research Coordinator, RP

Position Summary

This position will serve as a lead Clinical Research Coordinator for a Sleep Neurologist who studies the relationship between sleep and Alzheimer's disease pathology. This position requires an experienced Clinical Research coordinator who will coordinate clinical research trials in treatment of sleep disorders including diagnostic and therapeutic services, under PI supervision. The person who takes this position may be responsible for multiple research studies simultaneously, acting as a liaison with the PI, IRB, sponsoring agency, community and the study participants.

The role will be responsible for managing and recording all phases of study protocol as required by GCP and sponsoring agencies to ensure compliance. This role will be in person 2-3 days per week at the University of MN, Twin Cities campus and at clinical sites within the Twin City Metro area. Visa sponsorship and/ or relocation assistance not available for this position.

Work Schedule:

Hybrid (in-person 2-3 days a week), M-F, 7:30am - 4pm

50% - Research Study Visits:

• Independently identify, recruit, screen, and consent participants for sleep related research.
• Work with PI in determining participant eligibility based on diagnostic criteria and/or observations/analysis in participant interviews.
• Serve as research coordinator to lead clinical research study visits with participants in-person and remotely.
• Manage data entry from research visits in a timely and attentive to detail method.
• Ensure a safe physical environment for research participation when collecting sleep research which utilizes data using polysomnography, home sleep testing, single-channel EEG devices and actigraphy.
• Manage HIPAA compliant secure data storage of all study materials.
• Independently explain diagnostic procedures and study procedures and plans to participants.
• Independently administers/scores tests, route all lab and clinical in a timely manner to PI for evaluation.
• Lead and develop data collection methods and CRFs for study data.
• Independently perform assessments to ensure they are completed in a timely manner.

25% - Scheduling and Communication:

• Follow protocol to schedule and facilitate the patient's timely completion adhering to protocol requirements.
• Manage communications with PI, Sponsor, IRB, other regulatory groups, and participants as needed to ensure safety, adherence to protocol, AEs, SAES and understanding of studies.

20% - Regulatory, Compliance and Sponsor liaison:

• Comply with protocol guidelines, Good Clinical Practices (GCP), all applicable University guidelines, Standard operation procedures (SOPs), laws, and requirements of regulatory agencies.
• Coordinate site visits with industry sponsors; serve as a liaison with funding or sponsoring agencies.
• Manage IRB submissions, continuing annual reviews and Serious Adverse Event reporting (SAE); recommends protocol correction action plans as appropriate.

3% - Research protocol development:

• Works with principal investigator and collaborates with other investigators within the university to develop research studies as needed.

2% - Other duties:

• Performs other duties in addition to the work described above.

All required qualifications must be included in the application materials

Required Qualifications:

• BA/BS degree in a health-related field (Pre-Med, Psychology, Neuroscience, Nursing, etc.) plus at least four (4) years of work experience, or advanced degree plus 2 years of experience in research setting, or a combination of related education and work experience to equal eight (8) years of relevant experience.
• Experience with recruiting study participants and running research participant visits.
• Ability to collaborate with clinical sites to conduct research visits.
• Experience or Interest in learning how to complete remote participant visits.
• Experience problem solving and prioritizing essential clinical research components of a research participant visit.
• Organized with excellent attention to detail.
• Excellent verbal and written communication skills.
• Must demonstrate independence and interpersonal skills.
• Must comply with applicable laws, regulations, guidelines and…