Posted: Apr 02, 2019
Job Description: Responsible for monitoring oncology protocol compliance for all clinical trials coordinated by the Colorado Cancer Research Program (CCRP).
• Actively engages in the prevention, detection, and resolution of instances of conduct that do not conform to protocol requirements, CCRP policies and
procedures, FDA regulations, Good Clinical Practices, and IRB policies.
• Routinely audits patient charts and associated case report forms to assure compliance and quality control.
• Responsible for preparation, scheduling, facilitation, and management of all external audits.
• Responsible for creating and managing corrective and preventative action plans in response to internal and external audits.
• Responsible for patient registration/randomization.
• Assists Clinical Trial Coordinators with review and reporting of serious adverse events. Assures all adverse events are reported appropriately with accuracy
and that follow up is conducted as directed by protocol, FDA regulations, and ICH guidelines.
• Collaborates closely with the CCRP Clinical Research Team, which may include Clinical Trial Coordinators, the Principal Investigator (PI), Managers, the Drug
Accountability Coordinator, Sub-Investigators and Regulatory staff to ensure that key federal/state/local regulatory objectives are met; and that ethical
obligations are kept.
• Participates in project-related and departmental meetings as required. May participate in or lead cross-functional teams.
• Develops and maintains programs and processes to facilitate staff compliance with protocol requirements.
• Educates staff on current and changing FDA regulations, ICH guidelines, and SOPs.
• Demonstrates behaviors that reflect quality, professionalism, teamwork, and excellence.
• May attend relevant symposia, conferences and scientific meetings as necessary.
• Performs other duties as requested.
• Frequent use of computer, telephone and general office equipment (copiers, faxes, etc.) required.
• Frequent sitting, standing, walking, reading of documents, use of computer monitor screen and mouse, reaching with hands and arms, talking, writing and
• Occasional bending, grasping, twisting, carrying, stooping, kneeling, and crouching required.
• Frequent lifting and/or moving up to 20 pounds and occasional lifting and/or moving up to 40 pounds.
• Problem-solving skills and ability to independently analyze and interpret data required.
• Clear oral and written communication skills required for all interactions on behalf of CCRP with the public, physicians, affiliates and staff.
• Ability to travel locally to affiliate sites required.
• Working knowledge of Microsoft Office (word processing, computer spreadsheets, database use/maintenance and network file maintenance & management).
• Experience with interpreting complex protocols, subject records, and federal, state, and local regulations preferred.
• Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research.
• Demonstrates effective and efficient decision making capabilities daily and adjusts decisions to meet organizational requirements.
• Demonstrated knowledge of medical terminology and regulatory compliance.
• Acute awareness of confidentiality of information.
• This individual must be able to work as a member of a team, manage conflicts and resolve problems effectively.
• Detail-oriented organizational skills.
• Ability to complete tasks in an accurate and timely manner.
• Strong ability to multi-task and manage competing priorities while demonstrating excellent customer service behavior.
• Ability to constructively respond to organizational successes and development opportunities within the organization.
• Excellent interpersonal skills with proven written, presentation and verbal competencies.
• Experience using health-care based clinical information systems preferred.
• Valid driver’s license; must provide own transportation to affiliate sites as required.
• Bachelor's degree in scientific discipline, or an equivalent combination of training & experience.
• Minimum 2 years’ experience in health research and/or healthcare-related field preferred.
Interested Candidates should contact Lisa Switzer, MA, Director of Development & Human Resources at 303.777.2663 or email@example.com