Sr. Clinical Research Coordinator

Job Overview

We are looking for a motivated, highly organized, team-oriented person to join our Children's Oncology Group Research Team here at Children's Hospital Colorado! The Center for Cancer and Blood Disorders (CCBD) at Children's Hospital Colorado has one of the best pediatric hematology, oncology (cancer care) programs in the country. Children's Hospital Colorado is one of the highest accruing participating institutions within the Children's Oncology Group Consortium.

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.

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!

Location:

CCHRI – CCBD Clinical, Aurora Anschutz

Shift/

Hours:

Monday – Friday 0800 – 1630. Work hours may vary due to department needs. 40 hours per week, eligible for benefits.

• Documentation/Data Collection – prepares and participates in site initiation, monitoring, closeout visits, and document storage activities, related training, creation of SOPs and implementation of operational plans. Assembles 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 and 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. 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 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…