About the Job

Coordinate Clinical Research Studies & Participants (100%)
● Duties are determined by protocol-specific requirements and will include research activity from study startup through closeout and following participants from beginning to completion of the study.
● Follow Good Clinical Practice (GCP) guidelines in the conduct, performance and documentation of clinical research activities.
● Complete and maintain necessary training for safety, regulatory, facility access, and data system access.
● Facilitate study startup activities following guides and checklists to implement protocols, assess study related needs, create source documentation, visit checklists, and logs or other documents as required.
● Recruit interested individuals to participate in research projects and engage with the study team in verifying subject eligibility, facilitating subject enrollments, and ensuring compliance in the completion of research activities.
● Facilitate the completion of participant visits by scheduling appointments with participants and clinical staff following the protocol, providing necessary instructions, materials and reminders to participants, booking rooms, registering participants, and other tasks as needed.
● Obtain informed consent and assent, including assessments of capacity to consent to research. Obtain re-consent as needed.
● Conscientiously conduct research study activities to protect and promote participant safety, communicating clearly and promptly about any potential concerns
● Communicate information about assigned studies to other University faculty/staff, including details of study, inclusion/exclusion criteria, other enrollment requirements, visit needs, etc., leading training of study staff, clinical, and lab partners on study protocols activities as it relates to their roles on the study.
● Collaborate with the principal investigator/study team and with clinical providers and other departments to ensure smooth implementation and operation of the research protocol and study specific procedures are completed.
● Effectively work independently in multiple locations with hospital and clinic staff to complete research related tasks.
● Collect data and conduct assessments as part of study specific visits, in-person or remotely, following protocol specific guidelines, including data abstraction from medical records.
● Oversee specimen management for multiple projects, including monitoring the collection, processing, and storage or compliant shipment of research specimens to research laboratories, and return of results.
● Correctly and accurately completesource documentation for participant study-related visits along with other required documentation as needed; engage with providers and investigators to ensure adequate source documentation is available.
● Support timely and quality data submission and maintenance of participant research records.
● Complete and ensure appropriate documentation for any adverse-event (AE), serious adverse event (SAE) and protocol deviation, complying with reporting regulations and timelines, and notifying appropriate individuals/entities per research requirements.
● Use University systems such as Florence, OnCore, Box, Smartsheet, and REDCap to maintain information for all necessary research documentation.
● Monitor study suppliesand equipment, proactively ordering new as well as disposing of expired/unused items when needed, maintaining organization of items.
● Prepare for, schedule, and participate in pre-site selection visits, site initiation visits, monitoring visits, program audits, etc. by coordinating the visits and schedules, leading facility tours, and ensuring requested information is provided.
● In collaboration with the research team, interpret study protocols and inform the development of consent forms and other materials needed for each clinical research study.
● Maintain regulatory documents, such as: enrollment logs; participant visit logs; protocol deviation logs; etc

Qualifications

All required qualifications must be included in the application materials

Required Qualifications:
● BA/BS in a health related field plus 2 years of work experience in clinical research or a combination of related education and work experience in clinical research totaling 6 years
● Ability to work independently, make decisions, problem solve, maintain deadlines, and prioritize the simultaneous management of multiple clinical studies.
● Ability to follow strict protocols with the utmost ethical standards
● Knowledge of clinical research compliance standards, e.g. informed consent process, adverse event reporting, the Code of Federal Regulations (CFR) and Good Clinical Practices (GCP) Standards
● Computer proficiency and ability to navigate multiple software applications; experience with computerized data management
● Demonstrated accurate data management skills, such as data collection, data entry and quality control
● Excellent written, verbal and interpersonal skills
● On-site work 5 days per week
● Additional requirements per Fairview Research Administration may include proof of non-active tuberculosis and immunization for (or resistance to) measles, mumps, rubella, Hepatitis B, and pertussis and influenza. Additional background checks will be completed by Fairview Health Services as a condition of employment in this position.

Preferred Qualifications:
● Experience with business & industry trials
● Familiarity with the research policies and procedures at the University of Minnesota, University of Minnesota Medical Center, Fairview Hospitals and Clinics
● Experience with EPIC or other electronic medical records systems
● Proven detail-oriented with exceptional organizational, planning and problem-solving skills and ability to meet deadlines
● Certification as a Clinical Research Coordinator, or qualified to sit for the for the certification exam
● Phlebotomy experience

Pay and Benefits

Pay Range : $55,000-$70,000; 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

About the Job

Coordinate Clinical Research Studies & Participants (100%)
● Duties are determined by protocol-specific requirements and will include research activity from study startup through closeout and following participants from beginning to completion of the study.
● Follow Good Clinical Practice (GCP) guidelines in the conduct, performance and documentation of clinical research activities.
● Complete and maintain necessary training for safety, regulatory, facility access, and data system access.
● Facilitate study startup activities following guides and checklists to implement protocols, assess study related needs, create source documentation, visit checklists, and logs or other documents as required.
● Recruit interested individuals to participate in research projects and engage with the study team in verifying subject eligibility, facilitating subject enrollments, and ensuring compliance in the completion of research activities.
● Facilitate the completion of participant visits by scheduling appointments with participants and clinical staff following the protocol, providing necessary instructions, materials and reminders to participants, booking rooms, registering participants, and other tasks as needed.
● Obtain informed consent and assent, including assessments of capacity to consent to research. Obtain re-consent as needed.
● Conscientiously conduct research study activities to protect and promote participant safety, communicating clearly and promptly about any potential concerns
● Communicate information about assigned studies to other University faculty/staff, including details of study, inclusion/exclusion criteria, other enrollment requirements, visit needs, etc., leading training of study staff, clinical, and lab partners on study protocols activities as it relates to their roles on the study.
● Collaborate with the principal investigator/study team and with clinical providers and other departments to ensure smooth implementation and operation of the research protocol and study specific procedures are completed.
● Effectively work independently in multiple locations with hospital and clinic staff to complete research related tasks.
● Collect data and conduct assessments as part of study specific visits, in-person or remotely, following protocol specific guidelines, including data abstraction from medical records.
● Oversee specimen management for multiple projects, including monitoring the collection, processing, and storage or compliant shipment of research specimens to research laboratories, and return of results.
● Correctly and accurately completesource documentation for participant study-related visits along with other required documentation as needed; engage with providers and investigators to ensure adequate source documentation is available.
● Support timely and quality data submission and maintenance of participant research records.
● Complete and ensure appropriate documentation for any adverse-event (AE), serious adverse event (SAE) and protocol deviation, complying with reporting regulations and timelines, and notifying appropriate individuals/entities per research requirements.
● Use University systems such as Florence, OnCore, Box, Smartsheet, and REDCap to maintain information for all necessary research documentation.
● Monitor study suppliesand equipment, proactively ordering new as well as disposing of expired/unused items when needed, maintaining organization of items.
● Prepare for, schedule, and participate in pre-site selection visits, site initiation visits, monitoring visits, program audits, etc. by coordinating the visits and schedules, leading facility tours, and ensuring requested information is provided.
● In collaboration with the research team, interpret study protocols and inform the development of consent forms and other materials needed for each clinical research study.
● Maintain regulatory documents, such as: enrollment logs; participant visit logs; protocol deviation logs; etc

Qualifications

All required qualifications must be included in the application materials

Required Qualifications:
● BA/BS in a health related field plus 2 years of work experience in clinical research or a combination of related education and work experience in clinical research totaling 6 years
● Ability to work independently, make decisions, problem solve, maintain deadlines, and prioritize the simultaneous management of multiple clinical studies.
● Ability to follow strict protocols with the utmost ethical standards
● Knowledge of clinical research compliance standards, e.g. informed consent process, adverse event reporting, the Code of Federal Regulations (CFR) and Good Clinical Practices (GCP) Standards
● Computer proficiency and ability to navigate multiple software applications; experience with computerized data management
● Demonstrated accurate data management skills, such as data collection, data entry and quality control
● Excellent written, verbal and interpersonal skills
● On-site work 5 days per week
● Additional requirements per Fairview Research Administration may include proof of non-active tuberculosis and immunization for (or resistance to) measles, mumps, rubella, Hepatitis B, and pertussis and influenza. Additional background checks will be completed by Fairview Health Services as a condition of employment in this position.

Preferred Qualifications:
● Experience with business & industry trials
● Familiarity with the research policies and procedures at the University of Minnesota, University of Minnesota Medical Center, Fairview Hospitals and Clinics
● Experience with EPIC or other electronic medical records systems
● Proven detail-oriented with exceptional organizational, planning and problem-solving skills and ability to meet deadlines
● Certification as a Clinical Research Coordinator, or qualified to sit for the for the certification exam
● Phlebotomy experience

Pay and Benefits

Pay Range : $55,000-$70,000; 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