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.
• Exhibit excellence in coordination and communication for a highly busy team with multiple clinical and research responsibilities.
• Executes clinical trial procedures and subject care while complying with GCP -Records study data and maintains source documentation according to Good Documentation Practices
• Educate Gillette employees and departments, interns and non-Gillette Investigators involved with research at Gillette to the regulations, guidelines, processes and resources available.
• Contribution to processes and workflows for research utilizing flexibility and creativity amid a clinical research setting.
• Keep current on external regulations, laws and guidelines produced by various entities (federal, state, local, and sponsors).
• Anticipate, prevent and resolve issues while still managing day-to-day details of multiple concurrent studies.
• Meet multiple demands and deadlines amid disruption. Provide excellent communication, facilitation and problem solving while working with multiple internal and external customers.
• Provide coordination in clinical areas assigned working at an independent level
• Mentorship to CRCs across the organization.
• 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
• Develops accurate budgets in conjunction with Research Finance Analyst, PI and other appropriate Gillette staff tailored to specific funding sources (e.g. government, sponsors, internal).
• Obtains, negotiates and seeks approval of industry funded study budgets and contracts. Renegotiates budgets based on protocol changes when applicable.
• Facilitates site contract/subcontract/clinical trial agreement approval process by acting as liaison between Gillette and funding source.
• Builds Clinical Trial Management System (CTMS) templates for studies as well as use CTMS to monitor, reconcile and request corrections of study related subject visits and charges.
• Bachelor's degree
• CPR certification (or within 3 months of hire)
• Certification in Clinical Research (ie. Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or comparable certification through Association of Clinical Research Professionals (ACRP) or similar organization or university.
• 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
• Computer knowledge (use of all Microsoft products such as Access, Excel, PowerPoint, and Word)
• Ability to attend out-of-state meetings, as needed
• Familiarity with medical terminology
• Familiarity with IRB process and federal and state compliance and regulatory rules pertaining to research, confidentiality, and HIPAA
• Knowledge of statistics to interpret and analyze clinical data
• 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
About Gillette Children's Specialty Healthcare
Gillette Children's Specialty Healthcare is an independent pediatric hospital specializing in treating children who have complex conditions, rare disorders and traumatic injuries. Gillette providers treat patients - including adults who have conditions that began during childhood - who have medical needs that are often too complex for most other health care providers. We're different because of our focus. We center our care on conditions affecting the musculoskeletal and neurological systems. We also partner with Regions Hospital to operate Minnesota’s first Level I Pediatric Trauma Center.
In addition to our 60-bed hospital, we have eight primary clinic or hub locations, 11 outreach sites and one adult clinic. We serve more than 25,000 patients each year.
Our reach is local, national and global. Annually we serve patients from all Minnesota counties, nearly all 50 U. S. states and more than 10 countries.
Gillette is a Twin Cities Top Workplace and a National Top Workplace. We offer competitive pay, a strong benefits package and flexible schedules. Plus we give employees something that sets us apart: a chance to take part in our mission. Come to work for Gillette, and you’...ll improve the lives of countless children and adults who have disabilities or complex medical conditions.