Sr. Clinical Research Coordinator Epilepsy & Neuroimmunology Research Team

Clinical Research Coordinator Senior

The Clinical Research Coordinator Senior is a seasoned Coordinator who can work across multiple complex modalities and is responsible for participating in the day-to-day operations of complex, multi-site clinical research programs and/or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. Performs a variety of administrative and operational duties involved in the collection, compilation, documentation, and review of clinical research data.

Facilitates the accomplishment of research programs and/or study goals. Works independently and leads others in navigating the clinical research environment and participates in a variety of departmental and/or divisional initiatives. Provides oversight to Clinical Research Coordinators and other related team members. Works under minimal supervision.

We are looking for a motivated, detail-oriented, highly organized, team-oriented person to join the Neurology
- Epilepsy & Neuroimmunology team, here at Children's Hospital Colorado! Our extraordinary team at Children's Hospital Colorado is creating the future of child health, and we need top talent to do it. Join us!

Department: CCHRI - Operations
Hours per week: 40, eligible for benefits
Shift: Monday - Friday, 8am-4:30pm. Work hours may vary depending on needs of the department.

* This is a hybrid position.

• Documentation/Data Collection - Prepares and takes part in site initiation, monitoring, closeout visits, and document storage activities, and related training, creation of SOPs and implementation of operational plans. Assembles the necessary parties to ensure that all required agreements are in place. Utilizes and assists with training team members on electronic data capture systems, technologies, and software necessary for clinical research program and/or study operations.
  
  Scores tests, enters data, and completes required forms accurately and according to protocol. Leads the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies, identifies issues recommends solutions.
• Regulatory - Identifies and liaises with various regulatory partners (IRB, compliance, legal) as needed for clarity in effectively supporting research operations. Identifies gaps and participates in policy, standard operating procedures and guideline development as required to enhance research operations in the CHRE. Submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission.
• Study Participation - Screens, schedules, consents participants in a variety of clinical research programs and/or studies. Explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Conducts difficult, sensitive conversations with patients/families. Employs, evaluates, and assists with the implementation of innovative solutions to maximize recruitment and retention, and assists participants with individual needs. Collects information to determine feasibility, recruitment, and retention strategies.
  
  Collects, prepares, processes, ships, and maintains inventory of research specimens.
• Protocol - Develops and optimizes protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Conducts and documents visits and testing/interviews according to all regulatory and organizational protocols. Completes and submits along with regulatory team the AE reports, according to institution and sponsor-specific reporting requirements. Serves as a resource regarding institutional and sponsor-specific reporting requirements.
  
  Assists with the development of proposals or protocols. Identifies and communicates related shortcomings. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.
• Human Subject Research Protection - Maintains…