Clinical Research Coordinator I - Orthopedics

Gillette Children's•Saint Paul, MN

15h•$29 - $43•Hybrid

About The 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. 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.

Requirements

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)

Nice To Haves

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
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

Responsibilities

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.
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.
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