Clinical Research Coordinator I Spine

1.0 FTE; Monday Friday business hours. Some weekends may be required. Work locations include 200 and 205 University (primary location) and outlying clinics (Burnsville and Maple Grove) depending on Research Department needs. Opportunities for remote work as appropriate. This position will support the Spine Research Program. This role is expected to interact with patients and their families.

The Spine Program focuses on high quality studies aimed at improving the quality safety and value of pediatric spine care. Under the direction of Dr. Sara Morgan PhD and Dr. Daniel Miller MD Gillette investigators collaborate regularly with scientists orthotists therapists engineers and patients to design novel studies that address clinically relevant issues. Current areas of research include: determining the optional treatment for infantile idiopathic scoliosis; assessing the efficacy of part-time braces compared to traditional braces for adolescent idiopathic scoliosis; and understanding the long-term outcomes of pediatric spinal deformity into adulthood.

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 research coordination 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 and Benefits Information:

The hourly wage for this opportunity is $28.90 to $43.36 with a median wage of $36.13/ 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 for .5 FTE and above.

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/Masters degree in science or related medical field
• Able to perform height and weight measurements vital signs

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 Childrens 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 patientsfamilies 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 Childrens is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of an individuals 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 Childrens 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.

To learn more about working at Gillette Childrens please visit Childrens participates in the U.S. Department of Homeland Security (DHS) E-Verify program which is an internet-based employment eligibility verification system operated by the U.S. Citizenship and Immigration Services. If E-Verify cannot confirm that you are authorized to work Gillette will give you written instructions and an opportunity to contact DHS or the Social Security Administration (SSA) to resolve the issue before Gillette takes any further action. Please visit for further details regarding e-verify.

Required Experience:

IC