Clinical Research Coordinator I - Orthopedics

Clinical Research Coordinator I - Orthopedics

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 Orthopedics Research Program. This role is expected to interact with patients and their families.

The Orthopedics Program focuses on high quality studies aimed at improving the quality, safety, and value of pediatric spine care. Under the direction of Dr. Susan Novotny, PhD, and Dr. Jennifer Laine, 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: Perthes disease and other hip conditions, trauma and infection, limb length differences, upper extremity differences, clubfoot, and sports medicine.

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:

• 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.