University of Colorado Anschutz Medical Campus
Oncology Clinical Research Support Team Program Director
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80012
University Staff Description
University of Colorado Anschutz Medical CampusDepartment: Cancer CenterJob Title: Oncology Clinical Research Support Team Program DirectorPosition #00709595 - Requisition #35017Job Summary:The Oncology Clinical Research Support Team (OCRST) Program Director plays a pivotal role in advancing CU Cancer Center clinical research programs and initiatives including Investigator Initiated Trials (IIT), Lead Academic Performing Site (LAPS)/National Clinical Trial Network (NCTN) and Cancer Screening Research Network (CSRN) Administration, Oncology Research Information Exchange Network (ORIEN), and Data Quality.This position involves close collaboration with the Assistant Director of Clinical Research, the Associate Director of Clinical Research, IIT Review Committee Chair, and other CU Cancer Center leaders to define program objectives that align with the Cancer Center's overall strategic goals. Responsibilities include overseeing data reporting and quality control activities for the CU Cancer Center's Clinical Protocol and Data Management (CPDM) component, leading and facilitating meetings and activities across all assigned program areas. This position will be responsible for forecasting program staffing needs, developing and implementing comprehensive guidelines, policies and best practices within the scope of assigned responsibilities.Key Responsibilities:This position requires leadership, independent action, and the use of discretion and creativity within the limits of institutional, state and federal policies to facilitate the clinical research mission of the Cancer Center. This position will need to analyze existing policies, practices and precedents, as well as coordinate across multiple stakeholders and analyze and anticipate the probable consequences of various courses of action in order to develop strategies and processes to facilitate the clinical research goals of the center. This position requires a detailed understanding and complex analyses of multiple different needs, timelines and operational goals.Strategic Planning/Leadership 40%Provide administrative leadership of various clinical research initiatives and assigned program areas, such as: ORIEN, LAPS/NCTN, CSRN, IIT support, Data quality and reporting, and others as determined by Cancer Center leadership.Work with the Assistant Director of Clinical Research to implement the CU Cancer Center's clinical research objectives and coordinate the review and reporting on those objectives across the clinical research partners.Recommend strategies and practices to maintain/enhance the Center's compliance with all NCI, FDA, GCP and institutional guidelines related to the aforementioned OCRST activities.Provide leadership, management and oversight for administrative operations of OCRST including financial management (oversight and allocation of payroll and operating budgets), staffing of OCRST including management of any personnel contracts, and coordination of IT and facilities needs of the division with the Administrative Office.Serve as chair of the CU Cancer Center SOP workgroup; coordinate activities of workgroup to draft policies and procedures to support the necessary activities within the Cancer Center clinical research units; work with Cancer Center clinical and research leadership, and Cancer Center Administration, to develop consensus and support for the policies/processes across the various constituencies within the Cancer Center.Lead the CU Cancer Center OnCore Super Users workgroup as Chair: oversee and guide workgroup meetings and initiatives, establish and implement protocols for OnCore utilization across the Cancer Center, and address problem-solving and educational needs of end users.Represent OCRST to a variety of internal and external organizations including member institutions, funding agencies, Cancer Center and University leadership.
Department Oversight 40%Provide oversight of all OCRST activities and program areas including ensuring sufficient resources to support program needs and goals, supporting and facilitating the extension of those programs to the clinical research partners.In collaboration with OCRST Managers, Program Director(s) and staff, develop strategies and initiate guidelines, processes and standard practices to maintain and enhance the quality within OCRST areas of work.Support management team in supervision of OCRST staff including hiring, training, disciplinary actions, problem solving, and setting performance objectives.In collaboration with the Assistant Director for Clinical Research and OCRST Managers and Program Director(s), develop an annual budget for OCRST that provides projections of expenditures and staffing needs to support OCRST-specific activities and other consortium- and state-wide clinical research initiatives assigned within OCRST.Foster a collaborative working environment among OCRST program areas and between the Cancer Center clinical research units, leadership, and staff.
Data Reporting/Compliance 20%Ensure the timely and accurate reporting of clinical research activities to the NCI and other federal, state, and local agencies in support of the Cancer Center Support Grant (CCSG | P30CA046934), External Advisory Board (EAB), Cancer Center Governance Committee, and clinical trial operations. This includes preparing and delivering regular reports to the Assistant and Associate Directors of Clinical Research, Assistant Director of Research Administration, Disease Team Leadership, and other key stakeholders. These reports should include, but are not limited to, accruals, patient demographics for research projects, and trial opening timelines.Oversee data quality and quality assurance/quality control (QA/QC) activities: develop and implement robust data management frameworks to ensure accuracy, integrity, and reliability of clinical research data. Conduct regular audits and reviews to identify and address data discrepancies or compliance issues, and lead initiatives to enhance data collection, processing, and reporting practices. Provide training and guidance to team members on Cancer Center Support Grant (CCSG) data requirements and QA/QC procedures to maintain high-quality research outputs.
Work Location:Hybrid - this role is eligible for a hybrid schedule. Actual schedule is determined by departmental business needs.Why Join Us:The 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 elsewhereWhy work for the University?We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:Medical: Multiple plan optionsDental: Multiple plan optionsAdditional Insurance: Disability, Life, VisionRetirement 401(a) Plan: Employer contributes 10% of your gross payPaid Time Off: Accruals over the yearVacation Days: 22/year (maximum accrual 352 hours)Sick Days: 15/year (unlimited maximum accrual)Holiday Days: 10/yearTuition Benefit: Employees have access to this benefit on all CU campusesECO Pass: Reduced rate RTD Bus and light rail service
There are many additional perks & programs with the CU Advantage.Diversity and Equity: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 to request an accommodation in accordance with the Americans with Disability Act.Qualifications:Minimum Qualifications:Education: Bachelor's degree in business, science, nursing, healthcare or other related fields.Experience: Six (6) or more years of clinical research experience with at least two (2) years of direct personnel management experienceSubstitution: Professional clinical research management experience may substitute for the degree on a year for year basis
Applicants must meet minimum qualifications at the time of hire.Preferred Qualifications:A minimum of 4 years of personnel management including overseeing supervisor(s) or manager(s)Master's degree in a health, science or business fieldPrior oncology research experienceExperience working in an Academic institutionUnderstanding of requirements for NCI Designated cancer centersClinical Research certification (i.e. CCRC, CCRA, CCRP)
Knowledge, Skills and Abilities:Advanced knowledge of the academic center regulatory and clinical processes as related to clinical trials.Advanced knowledge of Good Clinical Practices, FDA rules and regulations in relation to clinical trials, and ICH regulations.Able to adapt and adjust quickly to help maintain a productive workflow across multiple departmentsExcellent interpersonal communication.Exceptional organization skills and advanced time-management skills.Ability to manage multiple direct reports and establish clear priorities supportive of organizational goals across multiple different projects and initiatives.An analytical mindset with excellent problem-solving skills.Commitment and leadership ability to advance diversity and inclusion
How to Apply: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 position2. Curriculum vitae / Resume3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email addressQuestions should be directed to: Jessica.Figura@cuanschutz.eduScreening of Applications Begins:Applications will be accepted until finalists are identified, but preference will be given to complete applications received by October 11 , 2024. Those who do not apply by this date may or may not be considered.Anticipated Pay Range:The starting salary range (or hiring range) for this position has been established as $79,212 - $92,679.The above salary range (or hiring 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/153125ADA Statement: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.Background Check Statement: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.Vaccination Statement:CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. 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.Application Materials Required: Cover Letter, Resume/CV, List of References Job Category: Research Services Primary Location: Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 20066 - SOM-U of Colo Cancer Center Schedule: Full-time Posting Date: Sep 27, 2024 Unposting Date: Ongoing Posting Contact Name: Jessica Figura Posting Contact Email: Jessica.Figura@cuanschutz.edu Position Number: 00709595
University of Colorado Anschutz Medical CampusDepartment: Cancer CenterJob Title: Oncology Clinical Research Support Team Program DirectorPosition #00709595 - Requisition #35017Job Summary:The Oncology Clinical Research Support Team (OCRST) Program Director plays a pivotal role in advancing CU Cancer Center clinical research programs and initiatives including Investigator Initiated Trials (IIT), Lead Academic Performing Site (LAPS)/National Clinical Trial Network (NCTN) and Cancer Screening Research Network (CSRN) Administration, Oncology Research Information Exchange Network (ORIEN), and Data Quality.This position involves close collaboration with the Assistant Director of Clinical Research, the Associate Director of Clinical Research, IIT Review Committee Chair, and other CU Cancer Center leaders to define program objectives that align with the Cancer Center's overall strategic goals. Responsibilities include overseeing data reporting and quality control activities for the CU Cancer Center's Clinical Protocol and Data Management (CPDM) component, leading and facilitating meetings and activities across all assigned program areas. This position will be responsible for forecasting program staffing needs, developing and implementing comprehensive guidelines, policies and best practices within the scope of assigned responsibilities.Key Responsibilities:This position requires leadership, independent action, and the use of discretion and creativity within the limits of institutional, state and federal policies to facilitate the clinical research mission of the Cancer Center. This position will need to analyze existing policies, practices and precedents, as well as coordinate across multiple stakeholders and analyze and anticipate the probable consequences of various courses of action in order to develop strategies and processes to facilitate the clinical research goals of the center. This position requires a detailed understanding and complex analyses of multiple different needs, timelines and operational goals.Strategic Planning/Leadership 40%Provide administrative leadership of various clinical research initiatives and assigned program areas, such as: ORIEN, LAPS/NCTN, CSRN, IIT support, Data quality and reporting, and others as determined by Cancer Center leadership.Work with the Assistant Director of Clinical Research to implement the CU Cancer Center's clinical research objectives and coordinate the review and reporting on those objectives across the clinical research partners.Recommend strategies and practices to maintain/enhance the Center's compliance with all NCI, FDA, GCP and institutional guidelines related to the aforementioned OCRST activities.Provide leadership, management and oversight for administrative operations of OCRST including financial management (oversight and allocation of payroll and operating budgets), staffing of OCRST including management of any personnel contracts, and coordination of IT and facilities needs of the division with the Administrative Office.Serve as chair of the CU Cancer Center SOP workgroup; coordinate activities of workgroup to draft policies and procedures to support the necessary activities within the Cancer Center clinical research units; work with Cancer Center clinical and research leadership, and Cancer Center Administration, to develop consensus and support for the policies/processes across the various constituencies within the Cancer Center.Lead the CU Cancer Center OnCore Super Users workgroup as Chair: oversee and guide workgroup meetings and initiatives, establish and implement protocols for OnCore utilization across the Cancer Center, and address problem-solving and educational needs of end users.Represent OCRST to a variety of internal and external organizations including member institutions, funding agencies, Cancer Center and University leadership.
Department Oversight 40%Provide oversight of all OCRST activities and program areas including ensuring sufficient resources to support program needs and goals, supporting and facilitating the extension of those programs to the clinical research partners.In collaboration with OCRST Managers, Program Director(s) and staff, develop strategies and initiate guidelines, processes and standard practices to maintain and enhance the quality within OCRST areas of work.Support management team in supervision of OCRST staff including hiring, training, disciplinary actions, problem solving, and setting performance objectives.In collaboration with the Assistant Director for Clinical Research and OCRST Managers and Program Director(s), develop an annual budget for OCRST that provides projections of expenditures and staffing needs to support OCRST-specific activities and other consortium- and state-wide clinical research initiatives assigned within OCRST.Foster a collaborative working environment among OCRST program areas and between the Cancer Center clinical research units, leadership, and staff.
Data Reporting/Compliance 20%Ensure the timely and accurate reporting of clinical research activities to the NCI and other federal, state, and local agencies in support of the Cancer Center Support Grant (CCSG | P30CA046934), External Advisory Board (EAB), Cancer Center Governance Committee, and clinical trial operations. This includes preparing and delivering regular reports to the Assistant and Associate Directors of Clinical Research, Assistant Director of Research Administration, Disease Team Leadership, and other key stakeholders. These reports should include, but are not limited to, accruals, patient demographics for research projects, and trial opening timelines.Oversee data quality and quality assurance/quality control (QA/QC) activities: develop and implement robust data management frameworks to ensure accuracy, integrity, and reliability of clinical research data. Conduct regular audits and reviews to identify and address data discrepancies or compliance issues, and lead initiatives to enhance data collection, processing, and reporting practices. Provide training and guidance to team members on Cancer Center Support Grant (CCSG) data requirements and QA/QC procedures to maintain high-quality research outputs.
Work Location:Hybrid - this role is eligible for a hybrid schedule. Actual schedule is determined by departmental business needs.Why Join Us:The 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 elsewhereWhy work for the University?We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:Medical: Multiple plan optionsDental: Multiple plan optionsAdditional Insurance: Disability, Life, VisionRetirement 401(a) Plan: Employer contributes 10% of your gross payPaid Time Off: Accruals over the yearVacation Days: 22/year (maximum accrual 352 hours)Sick Days: 15/year (unlimited maximum accrual)Holiday Days: 10/yearTuition Benefit: Employees have access to this benefit on all CU campusesECO Pass: Reduced rate RTD Bus and light rail service
There are many additional perks & programs with the CU Advantage.Diversity and Equity: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 to request an accommodation in accordance with the Americans with Disability Act.Qualifications:Minimum Qualifications:Education: Bachelor's degree in business, science, nursing, healthcare or other related fields.Experience: Six (6) or more years of clinical research experience with at least two (2) years of direct personnel management experienceSubstitution: Professional clinical research management experience may substitute for the degree on a year for year basis
Applicants must meet minimum qualifications at the time of hire.Preferred Qualifications:A minimum of 4 years of personnel management including overseeing supervisor(s) or manager(s)Master's degree in a health, science or business fieldPrior oncology research experienceExperience working in an Academic institutionUnderstanding of requirements for NCI Designated cancer centersClinical Research certification (i.e. CCRC, CCRA, CCRP)
Knowledge, Skills and Abilities:Advanced knowledge of the academic center regulatory and clinical processes as related to clinical trials.Advanced knowledge of Good Clinical Practices, FDA rules and regulations in relation to clinical trials, and ICH regulations.Able to adapt and adjust quickly to help maintain a productive workflow across multiple departmentsExcellent interpersonal communication.Exceptional organization skills and advanced time-management skills.Ability to manage multiple direct reports and establish clear priorities supportive of organizational goals across multiple different projects and initiatives.An analytical mindset with excellent problem-solving skills.Commitment and leadership ability to advance diversity and inclusion
How to Apply: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 position2. Curriculum vitae / Resume3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email addressQuestions should be directed to: Jessica.Figura@cuanschutz.eduScreening of Applications Begins:Applications will be accepted until finalists are identified, but preference will be given to complete applications received by October 11 , 2024. Those who do not apply by this date may or may not be considered.Anticipated Pay Range:The starting salary range (or hiring range) for this position has been established as $79,212 - $92,679.The above salary range (or hiring 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/153125ADA Statement: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.Background Check Statement: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.Vaccination Statement:CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. 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.Application Materials Required: Cover Letter, Resume/CV, List of References Job Category: Research Services Primary Location: Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 20066 - SOM-U of Colo Cancer Center Schedule: Full-time Posting Date: Sep 27, 2024 Unposting Date: Ongoing Posting Contact Name: Jessica Figura Posting Contact Email: Jessica.Figura@cuanschutz.edu Position Number: 00709595