Cardiology Clinical Trials Program Manager - 28024 University Staff

Description
University of Colorado | CU Anschutz Medical Campus

School of Medicine, Department of Medicine, Division of Cardiology

Official Title: Research Services Clinical Science Program Manager

Working Title: Cardiology Clinical Trials Program Manager

Position #804283 – Requisition #28024

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date. Information regarding this requirement, and exemptions can be found at:

Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2

Exemptions vary by campus location/department.

Campus/Unit-Specific Exemptions:

Anschutz Campus – Accommodations may be granted for medical or religious reasons.

The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.

The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here.

The School of Medicine's Division of Cardiology has an opening for a full-time University Staff (unclassified) Research Services Clinical Science Program Manager.

Jobs in the Research Services career family provide direct professional support of research activities. Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.

Program Managers are responsible for the day-to-day operation of a program, function or work unit, including the development and implementation of processes consistent with college, school or departmental strategies and processes.

Nature of Work

Clinical Science Program Managers perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Science Program Managers may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. Clinical Science Program Managers independently manage clinical research programs, perform clinical research project management functions and/or supervise clinical research teams of 2 or more FTE. Some Assignments will not move beyond this level.

We are seeking a Clinical Trial Program Manager in the areas of interventional cardiology and imaging research, electrophysiology, and heart failure. This position will support multiple Industry Supported Clinical Trials, Federally Funded Clinical Trials, and Investigator Initiated Clinical Trials. This position focuses primarily on the responsibility of managing the daily operations of the Cardiology Clinical Trials Program within the Division of Cardiology. This position will manage a team of research coordinators and will be responsible for ensuring that deadlines and goals are being appropriately met. The amount of time spent on required tasks may shift depending on the needs of the department.

Examples of Duties Performed

Managing Clinical Research Coordinators (40%) including:

• Evaluate study assignments and assess workload.
• Supervision, training and mentoring of Research Service Professionals, serving as clinical trial coordinators, in day-to-day processes and query resolutions.
• Conduct periodic audits of all the study documentation to ensure compliance and completeness.
• Develop, maintain, and update SOPs, training manuals, and coordinator processes to better increase program functionality
• Interview, hire, and train all new Research Service Professionals.
• Perform annual evaluations and additional reviews as needed of all Research Coordinators and Finance Coordinator.

Managing Study Start Up, Ongoing Study Activities, and Study Close Out (40%) including:

• Serve as the primary point of contact for industry partners, university partners, hospital partners, and key stakeholders.
• Perform study start up and close out procedures as needed for each study.
• Manage a research matrix to monitor the progress of all Clinical Trials within the Division of Cardiology.
• Assess feasibility and ongoing monitoring of clinical trial workload across the Division of Cardiology with the Division's Clinical Director of Research.
• Provide ongoing support for other research coordinators regarding the department's research processes and study-specific procedures.
• Work directly with industry sponsor monitors to ensure completeness of all work submitted.
• Troubleshoot database resolution.
• Monitor and track data entry, subject screening and enrollment activities, and troubleshoot areas where needed for compliance.
• Develop and submit accurate IRB applications, Continuing Review Reports and all other required documents to support the conduct of clinical trials research.
• Formulate consent documents in accordance with IRB regulations and sponsor-specific requests.
• Assist with the drafting of protocols, case report forms, and other required documents for Investigator Initiated trials.
• Provide direction and support for subject recruitment, tracking of study visit schedule appointments.
• Serve as a clinical research coordinator to obtain proper consents of subjects based on strict inclusion/exclusion criteria, as needed.
• Act as an advisor for junior faculty regarding research submissions, policies, and processes.
• Provide oversight of Good Clinical Practice in all studies.

Program Financial Management (20%) including:

• Direct all budget negotiations, start-up documentation, regulatory documentation, contracting, and re-negotiation for all studies.
• Ensure accurate fiscal management of all studies by performing monthly reviews.
• Ensure accurate invoices and payments are being properly recorded on a monthly/quarterly basis.
• Monitor financial accounts for discrepancies and continued financial success of the program.
• Allocate appropriate funding resources for clinical research coordinator salaries on a monthly basis.

This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Minimum Qualifications

• Bachelor's degree in any field
• A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis

Three (3) years clinical research or related experience

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications

• Bachelor's degree in science or health related field
• Five (5) years clinical research or related experience
• Prior experience providing program and/or project management duties in a clinical research setting
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)

Competencies, Knowledge, Skills, and Abilities

• Advanced knowledge of Good Clinical Practices, FDA Rules and Regulations, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical research.
• Knowledge of Redcap, OnCore, Central IRB, EDC, and/or Epic highly preferred
• Strong project management skills and experience within a complex and diverse environment
• Demonstration of strong analytical and problem-solving skills
• 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
• Knowledge of basic human anatomy, physiology medical terminology
• Ability to interpret and master complex research protocol information

Salary and Benefits

The salary range (or hiring range) for this position has been established at $62,687 - 79,737.

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

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 is not eligible for overtime compensation.

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.

Benefits: https://www.cu.edu/employee-services/benefits

Total Compensation Calculator: http://www.cu.edu/node/153125

Diversity and Equity

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@ucdenver.edu​.

The University of Colorado Denver | 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, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The University of Colorado Denver | 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.


Qualifications
Special Instructions to Applicants: Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references) Application Materials Required: Cover Letter, Resume/CV, List of References Application Materials Instructions: Application Deadline: Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Review of applications will begin immediately and will continue until the position is filled.

Job Category: Research Services

Primary Location: Aurora Department: U0001 -- DENVER & ANSCHUTZ MED CAMPUS - 20169 - SOM-MED-Cardiology

Schedule: Full-time

Posting Date: Nov 2, 2022

Unposting Date: Ongoing Posting Contact Name: Kelley Brodsky Posting Contact Email: Kelley.brodsky@cuanschutz.edu Position Number: 00804283





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