IIT Program Director - 33544 University Staff

Description

University of Colorado Anschutz Medical Campus

Department: Cancer Center

Job Title: IIT Program Director

Position #: 00797352 – Requisition #: 33544

Job Summary:

Supervision Exercised:

Examples of Work Performed:

IIT Program Oversight: 70%

• Oversee IIT protocol opening process across all pipeline studies, serve as a point of escalation, and intervene as necessary to resolve obstacles.

• Hold/conduct regular meetings with all IIT Program staff to review IIT portfolio, and status of studies in development, identify priorities or challenges, and intervene to ensure progress.

• Oversee IIT accrual monitoring activities, compile data for IIT Review Committee on underperforming studies, and assist with follow-up activities as needed.

• Review IIT Site Selection and Feasibility Questionnaires, identify any potential concerns or clarifications needed, and perform OCRST signoff.

• Review CAPA documents created by study teams in response to DSMC or other oversight entity requests before submission. Suggest changes or clarifications as necessary to ensure the responses submitted are clear, thorough, and fully address the issues identified.

• Ensures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Anschutz (CU Anschutz), National Cancer Institute (NCI) and other pertinent regulatory agencies.

• Identifies the need for policies, procedures, and educational materials as they relate to the Investigator-Initiated Trial (IIT) program. Work within the management team to develop, implement, and maintain OCRST policies and procedures concerning conducting IITs.

• Collaborates with OCRST Senior Financial Professional as needed during all phases of the study life cycle.

• Participate in IIT Incubator and IIT review committee meetings; collaborate with OCRST Program coordinator in setting agendas, ensure proper tracking and follow-up activities are completed.

Strategic Planning/Leadership 20%

• Participate in system implementation and developing standards for use (RedCap, Advarra EDC, eREG, project management software, and others)

• Provide regular reports to the Program Director and IIT leadership on program metrics including but not limited to study workloads and characteristics (multicenter, IND/IDE, etc), opening timelines, and accruals.

• Develop internal relationships with other CU Anschutz entities including CCTSI, CU Innovations, CRAO, clinical trial office/team leadership, and others that promote IIT development and operational success.

• Creates team objectives to meet the Cancer Center's overall strategic goals with guidance from the OCRST Program Director and Deputy Associate Director of Clinical Research.

• Collaborates with the Data Safety Monitoring Committee, Protocol Review Monitoring Committee, other OCRST program areas, and clinical trial office(s) on initiatives as needed.

• Attends and participates in leadership and management courses for growth and skill development.

• Support IIT program growth, work with the Director to forecast needs on an annual basis, develop JDs for new position needs.

Personnel Management 10%

• Supports management team in supervision of IIT program staff including hiring, training, disciplinary actions, problem-solving, and setting performance objectives.

• With input from the OCRST Program Director, handles personnel issues, including interviewing, hiring, performance evaluations, counseling, and disciplinary actions. Responsible for ensuring appropriate staffing levels. Conducts quality assurance audits of employee performance.

• Serves as a role model to all OCRST staff – remains in compliance with all training requirements, meets established deadlines, and possesses a strong understanding of clinical research, regulations, operations, and ethics.

• Guides FDA and Good Clinical Practice regulation to OCRST staff, clinical research teams, and investigators.

Work Location:

Hybrid

Why Join Us:

Position #: 00797352 – Requisition #: 33544

Job Summary:

Supervision Exercised:

Examples of Work Performed:

IIT Program Oversight: 70%

• Oversee IIT protocol opening process across all pipeline studies, serve as a point of escalation, and intervene as necessary to resolve obstacles.

• Hold/conduct regular meetings with all IIT Program staff to review IIT portfolio, and status of studies in development, identify priorities or challenges, and intervene to ensure progress.

• Oversee IIT accrual monitoring activities, compile data for IIT Review Committee on underperforming studies, and assist with follow-up activities as needed.

• Review IIT Site Selection and Feasibility Questionnaires, identify any potential concerns or clarifications needed, and perform OCRST signoff.

• Review CAPA documents created by study teams in response to DSMC or other oversight entity requests before submission. Suggest changes or clarifications as necessary to ensure the responses submitted are clear, thorough, and fully address the issues identified.

• Ensures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Anschutz (CU Anschutz), National Cancer Institute (NCI) and other pertinent regulatory agencies.

• Identifies the need for policies, procedures, and educational materials as they relate to the Investigator-Initiated Trial (IIT) program. Work within the management team to develop, implement, and maintain OCRST policies and procedures concerning conducting IITs.

• Collaborates with OCRST Senior Financial Professional as needed during all phases of the study life cycle.

• Participate in IIT Incubator and IIT review committee meetings; collaborate with OCRST Program coordinator in setting agendas, ensure proper tracking and follow-up activities are completed.

Strategic Planning/Leadership 20%

• Participate in system implementation and developing standards for use (RedCap, Advarra EDC, eREG, project management software, and others)

• Provide regular reports to the Program Director and IIT leadership on program metrics including but not limited to study workloads and characteristics (multicenter, IND/IDE, etc), opening timelines, and accruals.

• Develop internal relationships with other CU Anschutz entities including CCTSI, CU Innovations, CRAO, clinical trial office/team leadership, and others that promote IIT development and operational success.

• Creates team objectives to meet the Cancer Center's overall strategic goals with guidance from the OCRST Program Director and Deputy Associate Director of Clinical Research.

• Collaborates with the Data Safety Monitoring Committee, Protocol Review Monitoring Committee, other OCRST program areas, and clinical trial office(s) on initiatives as needed.

• Attends and participates in leadership and management courses for growth and skill development.

• Support IIT program growth, work with the Director to forecast needs on an annual basis, develop JDs for new position needs.

Personnel Management 10%

• Supports management team in supervision of IIT program staff including hiring, training, disciplinary actions, problem-solving, and setting performance objectives.

• With input from the OCRST Program Director, handles personnel issues, including interviewing, hiring, performance evaluations, counseling, and disciplinary actions. Responsible for ensuring appropriate staffing levels. Conducts quality assurance audits of employee performance.

• Serves as a role model to all OCRST staff – remains in compliance with all training requirements, meets established deadlines, and possesses a strong understanding of clinical research, regulations, operations, and ethics.

• Guides FDA and Good Clinical Practice regulation to OCRST staff, clinical research teams, and investigators.

Work Location:

Hybrid

Why Join Us:

33544

Job Summary:

Supervision Exercised:

Examples of Work Performed:

IIT Program Oversight: 70%

• Oversee IIT protocol opening process across all pipeline studies, serve as a point of escalation, and intervene as necessary to resolve obstacles.

• Hold/conduct regular meetings with all IIT Program staff to review IIT portfolio, and status of studies in development, identify priorities or challenges, and intervene to ensure progress.

• Oversee IIT accrual monitoring activities, compile data for IIT Review Committee on underperforming studies, and assist with follow-up activities as needed.

• Review IIT Site Selection and Feasibility Questionnaires, identify any potential concerns or clarifications needed, and perform OCRST signoff.

• Review CAPA documents created by study teams in response to DSMC or other oversight entity requests before submission. Suggest changes or clarifications as necessary to ensure the responses submitted are clear, thorough, and fully address the issues identified.

• Ensures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Anschutz (CU Anschutz), National Cancer Institute (NCI) and other pertinent regulatory agencies.

• Identifies the need for policies, procedures, and educational materials as they relate to the Investigator-Initiated Trial (IIT) program. Work within the management team to develop, implement, and maintain OCRST policies and procedures concerning conducting IITs.

• Collaborates with OCRST Senior Financial Professional as needed during all phases of the study life cycle.

• Participate in IIT Incubator and IIT review committee meetings; collaborate with OCRST Program coordinator in setting agendas, ensure proper tracking and follow-up activities are completed.

Strategic Planning/Leadership 20%

• Participate in system implementation and developing standards for use (RedCap, Advarra EDC, eREG, project management software, and others)

• Provide regular reports to the Program Director and IIT leadership on program metrics including but not limited to study workloads and characteristics (multicenter, IND/IDE, etc), opening timelines, and accruals.

• Develop internal relationships with other CU Anschutz entities including CCTSI, CU Innovations, CRAO, clinical trial office/team leadership, and others that promote IIT development and operational success.

• Creates team objectives to meet the Cancer Center's overall strategic goals with guidance from the OCRST Program Director and Deputy Associate Director of Clinical Research.

• Collaborates with the Data Safety Monitoring Committee, Protocol Review Monitoring Committee, other OCRST program areas, and clinical trial office(s) on initiatives as needed.

• Attends and participates in leadership and management courses for growth and skill development.

• Support IIT program growth, work with the Director to forecast needs on an annual basis, develop JDs for new position needs.

Personnel Management 10%

• Supports management team in supervision of IIT program staff including hiring, training, disciplinary actions, problem-solving, and setting performance objectives.

• With input from the OCRST Program Director, handles personnel issues, including interviewing, hiring, performance evaluations, counseling, and disciplinary actions. Responsible for ensuring appropriate staffing levels. Conducts quality assurance audits of employee performance.

• Serves as a role model to all OCRST staff – remains in compliance with all training requirements, meets established deadlines, and possesses a strong understanding of clinical research, regulations, operations, and ethics.

• Guides FDA and Good Clinical Practice regulation to OCRST staff, clinical research teams, and investigators.

Work Location:

Hybrid

Why Join Us:

Diversity and Equity:

Qualifications:

Minimum Qualifications:

• A bachelor's degree in public health, public administration, public policy, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, communications, or a directly related field from an accredited institution.

• Six (6) years of clinical research or related experience that included at least four (4) years of supervisory responsibilities and at least one (1) year of experience with Investigator Initiated Trials.

Applicants must meet minimum qualifications at the time of application.

Preferred Qualifications:

• Oncology experience (clinical or research).

• Experience working in an academic medical setting.

• Experience in teaching, precepting, and mentoring employees in clinical research.

Knowledge, Skills, and Abilities:

• Ability to communicate effectively, both in writing and orally.

• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

• Outstanding customer service skills.

• Demonstrated commitment and leadership ability to advance diversity and inclusion.

• Excellent interpersonal communication, organizational skills, and ability to problem solve and manage multiple priorities and deadlines.

• Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ from NCI-sponsored, private industry, and investigator-initiated clinical trials.

• Knowledge of clinical research financial activities (pre-award and post-award).

• Understanding of computer systems (specifically MS Office Suite, Teams, and Smartsheets) and ability to work efficiently within various applications.

• Knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials.

• Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology.

How to Apply:

Screening of Applications Begins:

Anticipated Pay Range:

or hiring range

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ADA Statement:

Background Check Statement:

Vaccination Statement:

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The Oncology Clinical Research Support Team (OCRST) provides comprehensive support for the Investigator-Initiated Trial (IIT) Program of the CU Cancer Center. IIT Program Director is responsible for providing oversight of functional areas of the IIT Program including regulatory affairs, clinical project management, and clinical data monitoring. This position works closely with the OCRST Program Director, IIT Review Committee Chair, and IIT Incubator leadership team to define Program objectives that align with the Cancer Center's overall strategic goals and participate in meetings and activities related to new IIT development and ongoing management of study portfolio. This position will assist the OCRST Program Director in forecasting program staffing needs, and identifying, creating, and managing guidelines, policies, and best practices for areas of responsibility. OCRST Clinical Project Manager, OCRST Regulatory Affairs Manager, OCRST Clinical Monitoring Manager, OCRST Program Coordinator

– this role is hybrid with the occasional need to be on campus in Aurora, CO.

The https://apptrkr.com/get_redirect.php?id=5241654&targetURL=IIT Program Director

The Oncology Clinical Research Support Team (OCRST) provides comprehensive support for the Investigator-Initiated Trial (IIT) Program of the CU Cancer Center. IIT Program Director is responsible for providing oversight of functional areas of the IIT Program including regulatory affairs, clinical project management, and clinical data monitoring. This position works closely with the OCRST Program Director, IIT Review Committee Chair, and IIT Incubator leadership team to define Program objectives that align with the Cancer Center's overall strategic goals and participate in meetings and activities related to new IIT development and ongoing management of study portfolio. This position will assist the OCRST Program Director in forecasting program staffing needs, and identifying, creating, and managing guidelines, policies, and best practices for areas of responsibility. OCRST Clinical Project Manager, OCRST Regulatory Affairs Manager, OCRST Clinical Monitoring Manager, OCRST Program Coordinator

– this role is hybrid with the occasional need to be on campus in Aurora, CO.

The https://apptrkr.com/get_redirect.php?id=5241654&targetURL=00797352 – Requisition #:

The Oncology Clinical Research Support Team (OCRST) provides comprehensive support for the Investigator-Initiated Trial (IIT) Program of the CU Cancer Center. IIT Program Director is responsible for providing oversight of functional areas of the IIT Program including regulatory affairs, clinical project management, and clinical data monitoring. This position works closely with the OCRST Program Director, IIT Review Committee Chair, and IIT Incubator leadership team to define Program objectives that align with the Cancer Center's overall strategic goals and participate in meetings and activities related to new IIT development and ongoing management of study portfolio. This position will assist the OCRST Program Director in forecasting program staffing needs, and identifying, creating, and managing guidelines, policies, and best practices for areas of responsibility. OCRST Clinical Project Manager, OCRST Regulatory Affairs Manager, OCRST Clinical Monitoring Manager, OCRST Program Coordinator

– this role is hybrid with the occasional need to be on campus in Aurora, CO.

The University of Colorado Cancer Center (https://apptrkr.com/get_redirect.php?id=5241654&targetURL=file:///C:/Users/gallk/Downloads/University of Colorado Cancer Center) stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: "Prevent and conquer cancer. Together." At the heart of our mission is the work to "unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education." Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere. The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, holidays, and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=5241654&targetURL=https://www.cu.edu/employee-services/benefits-wellness) .

At the University of Colorado Cancer Center (CU Cancer Center), we deem diversity in thought, perspective, lived experiences, and backgrounds to be essential for understanding and providing world-class health and cancer care to our diverse patient populations. We are, therefore, committed to the intentional development of a diverse, equitable, inclusive, and respectful academic community and workplace. We actively encourage individuals of all races, religions, national origins, genders, gender expressions, sexual orientations, ages, as well as veterans and individuals with disabilities to apply for positions at the CU Cancer Center. If you are an applicant with a disability, the University will provide reasonable accommodations throughout the employment application process. Please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5241654&targetURL=hr.adacoordinator@cuanschutz.edu) to request an accommodation in accordance with the Americans with Disability Act.

For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position 2. Curriculum vitae / Resume 3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address Questions should be directed to: Jessica.figura@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5241654&targetURL=Jessica.figura@cuanschutz.edu)

Screening begins on May 10, 2024. Those that apply after that date may or may not be considered.

The starting salary range () for this position has been established as $79,212 to $100,759. The above salary range () represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans, and retirement contributions that add to your bottom line. Total Compensation Calculator: http://www.cu.edu/node/153125 (https://apptrkr.com/get_redirect.php?id=5241654&targetURL=http://www.cu.edu/node/153125)

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5241654&targetURL=hr.adacoordinator@cuanschutz.edu) ​.

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get_redirect.php?id=5241654&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety-sensitive job duties, you must enroll in the occupational health medical surveillance program (https://apptrkr.com/get_redirect.php?id=5241654&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .

Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 20066 - SOM-U of Colo Cancer Center : Full-time : May 7, 2024 : Ongoing Posting Contact Name: Jessica Figura Posting Contact Email: Jessica.figura@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5241654&targetURL=Jessica.figura@cuanschutz.edu) Position Number: 00797352jeid-1813e8c2901489438066fb98e4b3e091

The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.