Senior Clinical Research Coordinator - Bone Marrow Transplant Research

Job Overview

We are looking for a motivated, highly organized, team-oriented person to join our Bone Marrow Transplant Research Team here at Children's Hospital Colorado. The BMT program is one of the most experienced pediatric bone marrow transplant programs in the country. Our team is the region's most experienced pediatric blood and marrow transplant and cellular therapy (BMT) program. We have performed more than 1,100 bone marrow transplants and have a growing cellular therapy program offering new, effective and less toxic therapies for a variety of diseases.

We're using it to pioneer treatments with the hope of eradicating childhood disease and changing pediatric medicine - giving all kids a chance at a healthier future.

We treat kids, adolescents and young adults from birth through mid-20s with cancer and non-malignant blood disorders. We provide access to breakthrough clinical trials to the patients and families we serve and pioneer treatments with the hope of eradicating childhood disease and changing pediatric medicine - giving all kids a chance at a healthier future.

Department: CCHRI - CCBD Clinical
Hours per week: 40, eligible for benefits

Shift: Monday - Friday, 8am to 4:30pm. Work hours may vary due to department needs.

* This position may have the possibility of being hybrid upon successful completion of department on-boarding/training and job performance.

• 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 compliance with institutional requirements and policies. Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. Serves as a resource and assists with the design of safeguards to ensure ethical conduct and to protect vulnerable populations and participates in sponsor required training. Serves as a resource and trainer for issues related to professional guidelines and code of ethics.
  
  Identifies and facilitates resolution of potential problems and risks to the participant, study and/or institution.
• Team Coordination - Leads team meetings. Proactively includes others in decision making and escalates issues to leadership as necessary. Provides significant contribution and influence upon research work, activities and/or productivity of study teams. Leads a…