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CHEManager International · 3 days ago

Research Professional 2 - Research Coordinator ROAR Team

Twin Lakes, MN

Full-time

Hybrid

Entry, Mid Level

$52K/yr - $65K/yr

2+ years exp

CHEManager International is seeking a Clinical Research Coordinator to support clinical research projects within the Department of Medicine at the University of Minnesota. The role involves coordinating clinical research studies, ensuring compliance with regulatory requirements, and managing participant interactions throughout the research process.

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Responsibilities

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 complete source 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 supplies and 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; personnel training records; recruitment/screening logs; randomization keys; device/account tracking logs; and other documentation as required

Support the study team in maintaining regulatory binders and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time

Duties may change or other duties may be assigned to meet the needs of the ROAR study portfolio

Qualification

Clinical Research CoordinationClinical Practice (GCP)Data ManagementInformed Consent ProcessAdverse Event ReportingRegulatory ComplianceElectronic Medical RecordsProblem SolvingInterpersonal SkillsOrganizational SkillsCommunication SkillsFlexibility

Required

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

Ability to work a flexible schedule, including occasional evening and weekends

On-site work 3-5 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

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