Clinical Research Manager (Lung/Neuro)

Clinical Research Manager (Lung/Neuro) - 34565 University StaffDescriptionUniversity of Colorado Anschutz Medical CampusDepartment: Cancer CenterWorking Title: Clinical Research Manager (Lung and Neuro)Position #: 00709255 – Requisition #: 34565Job Summary:Key Responsibilities:

Oversees 1 to 3 different disease sites at a given time.

Manages all staff updates in prescribed databases.

Manages all Protocol Amendments for disease sites and disseminates changes to team (budget, regulatory, and UCH team members) and updates prescribed databases. Promotes quality study flow and ensures all governing regulations are being adhered to. Reviews Medicare Analysis reviews for each new Amendment for applicable disease sites.

Acts as an interdepartmental liaison with UCH clinic staff (incl. investigators, nurses, clinic support staff, laboratory, pharmacy, radiology).

Plans and directs investigator and coordinator meetings (i.e. Initial orientations, study audits, closeout visits, physician meetings, research team meetings.) or delegates responsibility to team members as appropriate

Works with budget and regulatory specialist on escalation plans with Contract Research Organizations and Sponsors as needed for resolution of outstanding issues (i.e. financial payment, budget updates, and closeout costs.)

Oversees team schemas as studies are amended for eligibility, cohort changes, additional arms added, and study closeout.

Participates in cost savings/productivity strategies to meet or improve the department's operational budget; reviews quarterly finance reports for designated clinical research programs and works with the finance team to resolve discrepancies and review account balances on a regular basis. Provides review and corrections to quarterly financial/clinical dashboards.

Participates in preparation for, conduct of and generation of responses to external audits and FDA Inspections, and Data Safety Monitoring audits.

Collaborates with Data Safety Monitoring Committee, Protocol Review Monitoring Committee, and Oncology Clinical Research Support Team on initiatives.

Works with the Oncology Clinical Research Support Team staff on Investigator Initiated Trials reviewing protocol, amendment changes, and clinical toolkit.

Assists investigators with miscellaneous tasks as applicable (i.e. team reports, community engagement, full team and PI meetings).

Works with team Supervisor in regard to all clinical research personnel issues, including hiring, training and addressing performance issues with guidance from Clinical Program Director; conducts quality assurance audits of employee performance, oversees any technical or problem-solving issues as appropriate.

Manages workload balance/acuity across multiple teams and assures clinical research staff coverage is adequate to serve the needs of the Cancer Center.

Facilitates team building and cohesiveness across multiple disease sites.

Assists in the development implementation and maintenance of SOPs and internal processes.

Assists in the development, implementation, and maintenance of University of Colorado

CCTO Cancer Center Policies and Procedures in relation to conducting multiple clinical research trials.

Provides guidance regarding FDA and Good Clinical Practice regulation to clinical and investigator staff.

Work Location:HybridWhy Join Us:Why work for the University?

Medical: Multiple plan options

Dental: Multiple plan options

Additional Insurance: Disability, Life, Vision

Retirement 401(a) Plan: Employer contributes 10% of your gross pay

Paid Time Off: Accruals over the year

Vacation Days: 22/year (maximum accrual 352 hours)

Sick Days: 15/year (unlimited maximum accrual)

Holiday Days: 10/year

Tuition Benefit: Employees have access to this benefit on all CU campuses

ECO Pass: Reduced rate RTD Bus and light rail service

Diversity and Equity:Qualifications:Minimum Qualifications:

Bachelor's degree with a preferred emphasis in business, health administration, communications, biological or social science, or any other field of study related to the work assignment.

Closely related experience in a medical, clinical, research or clinical research environment may substitute for the degree on a year-for-year basis.

Five (5) years' clinical research experience

Two (2) years' clinical research or health care personnel management experience (can be included in above clinical research experience or can be from another healthcare related position)

Applicants must meet minimum qualifications at the time of hire.Preferred Qualifications:

Oncology experience (clinical or research)

Experience working simultaneously with various sponsors and studies in multiple phases.

Experience working in an academic medical setting.

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

Knowledge, Skills and Abilities:

Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task.

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

Knowledge of research study budgets

Understanding of computer systems (specifically MS Office Suite) and ability to work efficiently within various applications. Examples of work include creating treatment care plans for submission, utilizing workload management tools, and implementation or use of CTMS programs.

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, and NCI common toxicity definitions.

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

Ability to learn, interpret and master complex protocol information.

How to Apply:Screening of Applications Begins:August 22 nd , 2024.Anticipated Pay Range:$70,211-$82,147or hiring rangeADA Statement:Background Check Statement:Vaccination Statement:Job CategoryPrimary LocationSchedulePosting DateUnposting DateCopyright 2024 Jobelephant.com Inc. All rights reserved.Posted by the FREE value-added recruitment advertising agency (https://www.jobelephant.com/)The Clinical Research Manager is responsible for the implementation and conduct of clinical research trials in the Cancer Clinical Trials Office (CCTO) at the University of Colorado Cancer Center. This position is responsible for the oversight of all clinical studies and research staff in assigned programs. 40% Clinical Trial Management and Administration 40% Personnel Development and Management– This is not a remote position. This offer is contingent upon you working full-time, hybrid, on the Anschutz Medical Campus. You may be eligible to work a hybrid schedule after six months of employment. This benefit must be approved by your supervisor. In the event of departmental workload increase or special projects, you may be asked to report full-time on site until project completion.The University of Colorado Cancer Center (https://apptrkr.com/getredirect.php?id=5529741&targetURL=file://data.ucdenver.pvt/dept/som/cc/cc1/CCAdminHR/Personnel/CCTO Personnel/JD) 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 We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: There are many additional perks & programs with the CU Advantage (https://apptrkr.com/getredirect.php?id=5529741&targetURL=https://advantage.cu.edu/) .The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.Education Experience: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.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: melanie.f.schwartz@cuanschuitz.edu (https://apptrkr.com/getredirect.php?id=5529741&targetURL=melanie.f.schwartz@cuanschuitz.edu)Applications will be accepted until finalists are identified, but preference will be given to complete applications received by Those who do not apply by this date may or may not be considered.The starting salary range for this position has been established as: 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/getredirect.php?id=5529741&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/getredirect.php?id=5529741&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/getredirect.php?id=5529741&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/getredirect.php?id=5529741&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 : Aug 15, 2024 : Ongoing Posting Contact Name: Melanie Schwartz Posting Contact Email: melanie.f.schwartz@cuanschuitz.edu (https://apptrkr.com/getredirect.php?id=5529741&targetURL=melanie.f.schwartz@cuanschuitz.edu) Position Number: 00709255jeid-82719bdb8c755944bc8a0be731c18f72The 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.