University of Colorado Clinical Science Program Manager in Aurora, Colorado, United States

Job Information

University of Colorado Clinical Science Program Manager in Aurora, Colorado

Clinical Science Program Manager - 33067 University Staff

Description

University of Colorado Anschutz Medical Campus

School of Medicine | Department of Medicine

Job Title: Clinical Science Program Manager

Position: #00821011 – Requisition: # 33067

Job Summary:

Key Responsibilities:

Performs clinical research coordination and regulatory processes, procedures as defined in study protocol and in compliance with regulating bodies, including but not limited to, recruitment, enrollment, consent, conducting study visits, data entry, scheduling and conducting protocol activities.
Completes and manages regulatory submissions to local and central IRBs, FDA, and other regulatory agencies. Drafts regulatory documents and completes forms/paperwork.
Oversees study startup and regulatory processes.
Hiring, onboarding, and training of future research coordinators.
Direct supervisory duties of future clinical research coordinators, including evaluating and directing day-to-day work, coaching, and mentoring, and conflict management.
Performs processes related to study participant payments.
Adherence to all research standards and regulations set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies.
Implements processes and procedures to ensure harmonious clinical trial conduct and compliance, including writing and maintaining SOPs.
Formatting and editing scientific manuscripts for journal submission.
Project management and tracking across the study portfolio.
Scheduling and leading meetings.
Generate metrics and reports. Draft documents and presentations.
General administrative tasks related to the research portfolio.
Undertake special projects in collaboration with teams, supervisors and/or leadership.
Other duties as assigned by your supervisor.

Work Location:

Hybrid

Why Join Us:

Clinical Science Program Manager

Position: #00821011 – Requisition: #33067

Job Summary:

Key Responsibilities:

Performs clinical research coordination and regulatory processes, procedures as defined in study protocol and in compliance with regulating bodies, including but not limited to, recruitment, enrollment, consent, conducting study visits, data entry, scheduling and conducting protocol activities.
Completes and manages regulatory submissions to local and central IRBs, FDA, and other regulatory agencies. Drafts regulatory documents and completes forms/paperwork.
Oversees study startup and regulatory processes.
Hiring, onboarding, and training of future research coordinators.
Direct supervisory duties of future clinical research coordinators, including evaluating and directing day-to-day work, coaching, and mentoring, and conflict management.
Performs processes related to study participant payments.
Adherence to all research standards and regulations set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies.
Implements processes and procedures to ensure harmonious clinical trial conduct and compliance, including writing and maintaining SOPs.
Formatting and editing scientific manuscripts for journal submission.
Project management and tracking across the study portfolio.
Scheduling and leading meetings.
Generate metrics and reports. Draft documents and presentations.
General administrative tasks related to the research portfolio.
Undertake special projects in collaboration with teams, supervisors and/or leadership.
Other duties as assigned by your supervisor.

Work Location:

Hybrid

Why Join Us:

Job Summary:

Key Responsibilities:

Performs clinical research coordination and regulatory processes, procedures as defined in study protocol and in compliance with regulating bodies, including but not limited to, recruitment, enrollment, consent, conducting study visits, data entry, scheduling and conducting protocol activities.
Completes and manages regulatory submissions to local and central IRBs, FDA, and other regulatory agencies. Drafts regulatory documents and completes forms/paperwork.
Oversees study startup and regulatory processes.
Hiring, onboarding, and training of future research coordinators.
Direct supervisory duties of future clinical research coordinators, including evaluating and directing day-to-day work, coaching, and mentoring, and conflict management.
Performs processes related to study participant payments.
Adherence to all research standards and regulations set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies.
Implements processes and procedures to ensure harmonious clinical trial conduct and compliance, including writing and maintaining SOPs.
Formatting and editing scientific manuscripts for journal submission.
Project management and tracking across the study portfolio.
Scheduling and leading meetings.
Generate metrics and reports. Draft documents and presentations.
General administrative tasks related to the research portfolio.
Undertake special projects in collaboration with teams, supervisors and/or leadership.
Other duties as assigned by your supervisor.

Work Location:

Hybrid

Why Join Us:

Job Summary:

Key Responsibilities:

Performs clinical research coordination and regulatory processes, procedures as defined in study protocol and in compliance with regulating bodies, including but not limited to, recruitment, enrollment, consent, conducting study visits, data entry, scheduling and conducting protocol activities.
Completes and manages regulatory submissions to local and central IRBs, FDA, and other regulatory agencies. Drafts regulatory documents and completes forms/paperwork.
Oversees study startup and regulatory processes.
Hiring, onboarding, and training of future research coordinators.
Direct supervisory duties of future clinical research coordinators, including evaluating and directing day-to-day work, coaching, and mentoring, and conflict management.
Performs processes related to study participant payments.
Adherence to all research standards and regulations set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies.
Implements processes and procedures to ensure harmonious clinical trial conduct and compliance, including writing and maintaining SOPs.
Formatting and editing scientific manuscripts for journal submission.
Project management and tracking across the study portfolio.
Scheduling and leading meetings.
Generate metrics and reports. Draft documents and presentations.
General administrative tasks related to the research portfolio.
Undertake special projects in collaboration with teams, supervisors and/or leadership.
Other duties as assigned by your supervisor.

Work Location:

Hybrid

Why Join Us:

Diversity and Equity:

Qualifications:

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.
Four (4) 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) yeas clinical research or related experience.
Prior project management experience in a clinical research setting.
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems) and REDCap.
Personnel management experience.
Experience working in an academic institution.
Experience writing policies and procedures.
Experience with research budget development for sponsored projects.
Experience with NIH-sponsored and industry clinical research studies, including multi-center clinical trials.
Experience with Epic (UCH electronic medical record system) and CTMS systems (Oncore).

Knowledge, Skills, and Abilities:

Strong project management skills and experience within a complex and diverse environment.
Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
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, and medical terminology.
Ability to interpret and master complex research protocol information.
Ability to work independently following training.
Knowledge and familiarity with clinical research study conduct.
Ability to read, interpret and implement complex research protocol information.
Respect for patient rights and dedication to patient safety and protections; excellent patient rapport.
Ability to work with colleagues and patients in a confidential and professional manner.
Ability to follow and execute a study protocol and proactively prevent deviations.
Ability to follow direction of the PI and direct supervisor, follow all department SOPs and department policies.
Critical, independent thinking and sound judgement.
Outstanding organizational and time management skills with an attention to detail.
Basic statistical skills.
Research training: CITI, GCP, IATA, blood borne pathogens, Basic Life Support (BLS).
Familiarity eCRF databases.

How to Apply:

Screening of Applications Begins:

Anticipated Pay Range:

or hiring range $67,403- $85,736 .

or hiring range

ADA Statement:

Background Check Statement:

Vaccination Statement:

Qualifications

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The Department of Medicine (DOM) has an opening for a full-time Research Services Clinical Science Program Manager to provide conduct and supervisory oversight of additional clinical research coordinators for a variety of drug, device and biologic studies conducted at the University of Colorado Anschutz Medical Campus and affiliate hospitals. This position will oversee future clinical research coordinators, act as lead or co-lead coordinator overseeing coordinating activities for assigned studies, and as a primary contact for training and guidance for other coordinators supporting these studies. This position will have independent decision making and project management responsibilities. We are seeking an individual who is collaborative, detail oriented, organized, proactive, able to think critically, focused on quality, passionate about research, and highly motivated in all areas of study coordination.

– this role is eligible for a hybrid schedule of 4 days per week on campus. One remote day per week is allowed, in consultation with your supervisor. Participant schedules and team priorities may often preclude remote work.

The Department of Medicine has more than 1,000 faculty, 192 residents and 200 fellows distributed in 14 divisions. Our clinical, research and academic programs attract the best providers, investigators, staff and students from around the world who are transforming the future of health care. When you join our team of eminent scientists and physicians, you will be part of our research mission to create an integrated research ecosystem that makes transformative discoveries to improve lives. We are dedicated to our staff and their professional development across the course of their careers. 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://apptrkr.com/get_redirect.php?id=5135546&targetURL=

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, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

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: Trisha Loftin, trisha.loftin@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5135546&targetURL=trisha.loftin@cuanschutz.edu)

Immediately and continues until the position is filled. For best consideration, apply by April 22, 2024.

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/get_redirect.php?id=5135546&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=5135546&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=5135546&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=5135546&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 - 20153 - SOM-MED GENERAL OPERATIONS : Full-time : Mar 25, 2024 : Ongoing Posting Contact Name: Trisha Loftin Posting Contact Email: trisha.loftin@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5135546&targetURL=trisha.loftin@cuanschutz.edu) Position Number: 00821011jeid-4a79c77aa55cbe48be24ecc290067109

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.

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University of Colorado Clinical Science Program Manager in Aurora, Colorado

University of Colorado

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