Job ID: 376144
About the Job
Clinical Research Coordinator Manager Solid Tumor
The CRC Manager for the Masonic Cancer Center's (MCC) Clinical Trials Office (CTO) will assist the CTO Clinical Director in development, oversight and supervision of the CTO Clinical Research Coordinator (CRC) Team. In addition to assisting with day-to-day management of the adult CRCs, this position will be responsible for Collaborate with MCC, CTO, MHealth Fairview leaders, investigators and study teams to develop and implement project plans and continuous quality/performance improvement initiatives to optimize resourcing plans and ensure efficient management of the clinical research portfolio.
KEY RESPONSIBILITIES
40% - CRC Management: Foster an environment of excellence for the CTO's CRC team that supports the mission, vision, goals and objectives of the CTO. Work collaboratively with Program Managers and CTO Clinical Leadership to manage assigned CRC workload within their respective disease groups, ensuring balanced support across disease teams. Identify staffing deficiencies using objective workload criteria, and reassign CRCs as needed.
30% - Performance Management: Provide ongoing leadership in quality improvement and quality assurance initiatives that pertain to the clinical practice of CRCs in the CTO. Ensure research documentation and protocol compliance is maintained at high standards consistent with monitoring and auditing requirements and research regulations. Perform data extractions at specified intervals to ensure the team is on track with goal attainment, and to ensure newly hired team members meet the CTO's standards for quality of work.
15% - People Management: Recruit, hire, develop and retain highly engaged and competent staff. Manage, mentor and evaluate assigned staff. Work with CRC team members to set expectations for practice that align with their classification, create clear pathways for promotions and align team members individual goals with these pathways, define skills and attributes specific to each CRC classification (I-IV) with objective criteria for meeting each qualification, and work with team members that do not perform to expectations to create a measurable and time dependent pathway for success. Engage staff in cross-functional process improvement work and identify opportunities for continuing education for staff growth and engagement.
10% - Risk Mitigation & Compliance: Assure compliance with all applicable regulatory standards. Establish and maintain proficiency with applicable guidelines and rules that define conduct, performance, monitoring, auditing, and reporting for CTO clinical trials. Regularly audit staff billing to mitigate risk and ensure financial health of CTO clinical operations.
5% - Quality Assurance: Maintain all clinical operations unit policies and procedures ensuring compliance with organization goals and all applicable regulatory requirements. Assist study team, Program Managers, Regulatory, and Clinical leadership with audit requests from internal auditors or any relevant regulatory authorities.
Qualifications
All required qualifications must be documented on application materials.
REQUIRED EDUCATION/QUALIFICATIONS
About the Job
Clinical Research Coordinator Manager Solid Tumor
The CRC Manager for the Masonic Cancer Center's (MCC) Clinical Trials Office (CTO) will assist the CTO Clinical Director in development, oversight and supervision of the CTO Clinical Research Coordinator (CRC) Team. In addition to assisting with day-to-day management of the adult CRCs, this position will be responsible for Collaborate with MCC, CTO, MHealth Fairview leaders, investigators and study teams to develop and implement project plans and continuous quality/performance improvement initiatives to optimize resourcing plans and ensure efficient management of the clinical research portfolio.
KEY RESPONSIBILITIES
40% - CRC Management: Foster an environment of excellence for the CTO's CRC team that supports the mission, vision, goals and objectives of the CTO. Work collaboratively with Program Managers and CTO Clinical Leadership to manage assigned CRC workload within their respective disease groups, ensuring balanced support across disease teams. Identify staffing deficiencies using objective workload criteria, and reassign CRCs as needed.
30% - Performance Management: Provide ongoing leadership in quality improvement and quality assurance initiatives that pertain to the clinical practice of CRCs in the CTO. Ensure research documentation and protocol compliance is maintained at high standards consistent with monitoring and auditing requirements and research regulations. Perform data extractions at specified intervals to ensure the team is on track with goal attainment, and to ensure newly hired team members meet the CTO's standards for quality of work.
15% - People Management: Recruit, hire, develop and retain highly engaged and competent staff. Manage, mentor and evaluate assigned staff. Work with CRC team members to set expectations for practice that align with their classification, create clear pathways for promotions and align team members individual goals with these pathways, define skills and attributes specific to each CRC classification (I-IV) with objective criteria for meeting each qualification, and work with team members that do not perform to expectations to create a measurable and time dependent pathway for success. Engage staff in cross-functional process improvement work and identify opportunities for continuing education for staff growth and engagement.
10% - Risk Mitigation & Compliance: Assure compliance with all applicable regulatory standards. Establish and maintain proficiency with applicable guidelines and rules that define conduct, performance, monitoring, auditing, and reporting for CTO clinical trials. Regularly audit staff billing to mitigate risk and ensure financial health of CTO clinical operations.
5% - Quality Assurance: Maintain all clinical operations unit policies and procedures ensuring compliance with organization goals and all applicable regulatory requirements. Assist study team, Program Managers, Regulatory, and Clinical leadership with audit requests from internal auditors or any relevant regulatory authorities.
Qualifications
All required qualifications must be documented on application materials.
REQUIRED EDUCATION/QUALIFICATIONS
- BA/BS Undergraduate degree and a minimum of 6 years of clinical research coordination experience, or equivalent combination of education and experience.
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