Clinical Research Coordinator I - Gait and Motion Analysis

The Clinical Research Coordinator I will support the Gait and Motion Analysis Research Program in a 1.0 FTE (40hours/week) position, Monday - Friday, within standard business hours (some weekends may be required). This position will be based out of the 205 University location in the Gait Lab (primary location), with travel to outlying clinics, depending on Research Department needs.

This is a primarily onsite position, however there will be opportunities to work remotely. The selected candidate must reside in Minnesota or Wisconsin and have the ability to work onsite in St. Paul, MN several times per week. Relocation to the area is expected for out-of-state applicants.

The Gait Lab Program focuses on high quality studies aimed at understanding movement disorders resulting from cerebral palsy and other conditions. Gillette investigators collaborate with research scientists, therapists, engineers, and patients to design novel research studies that address clinically relevant issues for children with movement disorders. The James R. Gage Center for Gait and Motion Analysis is known worldwide for their expertise in diagnosing and planning treatments for people who have walking and movement disorders. This has helped the Center to be one of the busiest and most respected clinical gait and motion analysis centers in the world.

Purpose of position:

The Clinical Research Coordinator (CRC) has significant responsibility and works to serve as an integral member of the clinical research team by leading coordinator for a designated clinical area, providing back-up to other areas as assigned. The person in this role acts as a liaison and communicator between clinicians, sponsoring agencies, Institutional Review Board (IRB), hospital departments/employees and patients to facilitate the start-up, implementation, coordination and close out of research projects.

Compensation & Benefits:

The hourly wage for this opportunity is $28.90/hour to $43.36/hour, with a median wage of $36.13/hour. Pay is dependent on several factors including relevant work experience, education, certification & licensure, and internal equity. Hourly pay is just one part of the compensation package for employees. Gillette supports career progression and offers a competitive benefits package that includes a retirement savings match, tuition and certification reimbursement, paid time off, and health and wellness benefits.

Core Responsibilities and Duties:

Study Management

Organizes and facilitates study team meetings Contributes to protocol development, helps determine protocol feasibility,

and coordinates protocol approval processes. Recommends and implements protocol amendments as needed. * Coordinates and establishes study schedule, clinical study activity assignments and allocation of staff and equipment. * Develops and/or evaluates congruence of data collection tools (e.g. data dictionary, case report forms (CRF), electronic data capture (EDC) with the study protocol. * Completes IRB application and amendments, continuing reviews, and other study related documents (consent, assent and HIPAA forms, patient recruitment materials, etc.). Leads screening and recruitment processes for study subjects Leads consent and enrollment process when appropriate. Coordinates and manages study per protocol activities and carries out

appropriate data collection systems and procedures. * Conducts clinical study activity such as phlebotomy and specimen processing, vital signs, ECGs, height and weight, and other tasks as appropriately delegated by PI and record data and results. * Serves as liaison to sponsors and outside agencies and collaborators as needed. * Provides status updates/reports and manages monitor visits and required activities. Responsible for compiling and reporting protocol activity to study team and providing input and problem solving when needed. Facilitates and conducts close-outs and archiving activities. Works with Investigators on grant application(s) to ensure a smooth and

timely submission.

Safety

* Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards. * Oversees safety risks (e.g. clinical holds, product recalls) to minimize potential risks to subject safety. * Informs the sponsor and IRB of any changes to the protocol or safety concerns and submit progress reports to the IRB per requirements. * Ensures adverse event reporting is documented appropriately and maintains follow-up to determine AE resolution. Reviews common laboratory values and alerts. Maintains familiarity with and follows internal/external research

guidelines/processes: Federal Drug Administration (FDA) Code of Federal Regulations, FDA guidelines, International Conference of Harmonization Good Clinical Practice (ICH GCP), IRB, National Institution of Health (NIH) and Gillette policies. * Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Pre and Post Award

* If applicable, works with Investigators on grant application(s) to ensure a smooth and timely submission. Maintains working knowledge of study contract and scope of work. Monitors, reconciles and requests corrections of study related subject visits

to ensure that invoicing can accurately take place * Provides consultation to Research Financial Analyst regarding study related expenditures (i.e. study visits, participant reimbursement and time) for invoicing when applicable. Responsible for compiling and reporting protocol activity to study team. Communicates to Research Finance Analyst when study close-out needs to be

conducted and consults in this process as needed. Contributes to grant and sponsor budget formation Participates in completion and execution of contracts as assigned

Qualifications:

Required:

High school diploma/GED Computer knowledge (use of all Microsoft products such as Access, Excel,

PowerPoint, and Word) Ability to attend out-of-state meetings, as needed CPR certification (or within 3 months of hire)

Preferred:

Knowledge of statistics to interpret and analyze clinical data Bachelors/Master’s degree in science or related medical field Able to perform height and weight measurements, vital signs, phlebotomy, ECG

and carry out laboratory procedures

Knowledge, Skills and Abilities:

Good critical thinking skills Able to take initiative and perform job responsibilities at an independent

level * Able to communicate and facilitate a busy clinical research team with multiple clinical and research responsibilities. Strong attention to detail Excellent customer service skills Positive, encouraging attitude Capable of managing multiple projects Interest in continued learning regarding clinical area of research Familiarity with medical terminology

At Gillette Children’s, we foster a culture where every team member feels a sense of belonging and purpose. We are dedicated to building an environment where all feel welcomed, respected, and supported. Our values are embedded at the heart of our culture. We act first from love, embrace the bigger picture, and work side-by-side with our patients, families, and colleagues to help every child create their own story. Together, we work to ensure patients of all backgrounds and abilities reach their full potential.

Gillette Children's is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of an individual's race, color, creed, sex, religion, national origin, age, disability, marital status, familial status, genetic information, status with regard to public assistance, sexual orientation or gender identity, military status or any other class protected by federal, state or local laws.

Gillette Children’s is a global beacon of care for patients with brain, bone and movement conditions that start in childhood. Our research, treatment and supportive technologies enable every child to lead a full life defined by their dreams, not their diagnoses.

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