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Clinical Research Lead/Program Manager

Clinical Research Lead/Program Manager - 29249 University Staff

Description
University of Colorado Anschutz Medical Campus

Department: Orthopedics

Job Title: Open Rank Clinical Research Principal Professional/Clinical Research Program Manager

Position: # 00807588 – Requisition: #29249

Job Summary:

The University of Colorado Department of Orthopedics has an opening for two (2) Clinical Research Leads/Program Managers who will serve a critical role in launching and managing the daily operations of the Department's new Clinical Research Support Core. These positions will be part of exciting change as CU Orthopedics develops its Clinical Research Division and will contribute to the meaningful work of creating a centralized support structure for clinical research assistants. The primary focus area of these positions is the management of the Clinical Research Support Core. This includes direct oversight of Core team members and indirect leadership to other clinical research professionals throughout the Department. These roles will collaborate with Department research leadership to improve efficiency of clinical research management including study launch processes and ongoing operations, communication with and support of clinical research team members, regulatory oversight, and establish an improved pathway to success for clinical researchers. The secondary responsibility of these positions is to serve as Clinical Research Coordinator for Principal Investigators who utilize the Clinical Research Support Core. This includes managing regulatory submissions, ensuring compliance with applicable rules and regulations, serving as Department liaison with study sponsors, interacting with patients during study visits, and completing other required activities and documentation pertaining to sponsored clinical studies.

One position will focus on clinical research projects that are conducted at the University of Colorado Anschutz Medical Campus and UCHealth/CU Medicine clinics, and the other position will focus on projects taking place at Children's Hospital Colorado.

These are hybrid remote and in-office positions with occasional travel to clinics throughout the Denver metro area.

Key Responsibilities:

Principal Professional and Program Manager Levels

The duties and responsibilities of the positions include but are not limited to:
    Collaborate with Department clinical research leadership to improve policies and procedures of Core
  • Assist with creation of pre-research application that will document Principal Investigator's project plans and research support needs
  • Help establish new Clinical Research Review Committee that will evaluate applications to utilize Core services and make selections based on pre-determined factors including feasibility and study coordinator time commitment
  • Monitor workload and distribute among team members
  • Serve as Department's Primary Point of Contact and Subject Matter Expert for clinical research, including answering questions related to compliance, regulatory submissions, and ongoing management of clinical trials
  • Establish a structure of oversight and regular communication with each individual research program within Clinical Orthopedics
  • Support Clinical Research Director with ad-hoc projects

Program Manager Level Only
    Develop new processes to track clinical research metrics and create new reports for senior research leadership. Devise new strategies for improving various aspects of clinical research management, including but not limited to helping speed up study launch timelines, making more accurate feasibility assessments, better meeting enrollment targets, and improving clinical research communications/education across the Department. Create and implement processes to run the new Clinical Research Support Core; be responsible for daily operations of Core. Act as Lead Department Liaison in the event of internal and external audits.

Why Join Us:

CU Medicine Orthopedics has an expert team of Orthopedic providers that consists of fellowship-trained surgeons and specialists who provide the highest quality, comprehensive care for your orthopedic needs. Using cutting-edge technology and minimally invasive techniques, we offer access to the most advanced procedures to get you back to your life as quickly as possible. From foot and ankle issues to total replacements along with spine and sports medicine injuries, we provide full-service orthopedic care. We also have providers who specialize in pediatric orthopedics to treat younger patients with customized care.

Diversity and Equity:

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.

Qualifications:

Minimum Qualifications

Principal Professional Level

Applicants must meet minimum qualifications at the time of hire.
  • Education: Bachelor's degree in biology, physiology, kinesiology, engineering, or a related field.
  • Related experience: three (3) years of experience conducting clinical research
  • Minimum one year of experience directly supervising other employee(s)
  • 1 year of clinical research experience may be substituted with a Master's degree in a related field

Program Manager Level
  • Education: Bachelor's degree in biology, physiology, kinesiology, engineering, or a related field.
  • Related experience: four (4) years of experience conducting clinical research
  • Minimum one year of experience directly supervising other employee(s)
  • 1 year of clinical research experience may be substituted with a Master's degree in a related field

Preferred Qualifications

Principal Professional and Program Manager Levels
    ACRP or SOCRA Certification Experience managing research teams and developing and implementing a variety of operational systems and training programs Experience with navigation of external audits For the CU/UCH-focused position, experience with navigating CU Medicine/UCHealth research process, systems, and clinics For the CHCO-focused position, experience with navigating Children's Hospital Colorado research processes, systems, and clinics

Knowledge, Skills, and Abilities

To be successful in these positions, candidates will need the following attributes and skills:
    Team-oriented with interest and experience in developing a team Detail-oriented with an ability to appreciate the big picture Skilled at organization and time management Effective communication skills to facilitate interactions across different programs and positions within Orthopedics Interacts effectively with colleagues, researchers, sponsors, and study participants Highly flexible when priorities shift as Department develops a brand-new structure for supporting clinical research Excellent problem-solving skills with the ability to tactfully address any challenges Proficiency with Microsoft Office: Word, Excel, PowerPoint, Outlook, Teams Strong ability to work independently, multitask, and meet deadlines Commitment to the research mission of the Department of Orthopedics

How to Apply:

For full consideration, please submit the following document(s):
    A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position Curriculum vitae / Resume Three to five professional references including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Katherine Dwyer-Clonts, KATHERINE.DWYER-CLONTS@CUANSCHUTZ.EDU

Screening of Applications Begins:

Screening begins immediately and continues until the position has been filled.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as:

Principal Professional $60,075-$76,415

Program Manager $62,687-$79,737

The above 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/153125

ADA 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:

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

Unit-Specific Exemptions:
    Anschutz Campus – Accommodations may be granted for medical or religious reasons.

The University of Colorado 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.
Application Materials Required: Cover Letter, Resume/CV, List of References

Job Category: Research Services

Primary Location: Aurora Department: U0001 -- DENVER & ANSCHUTZ MED CAMPUS - 20259 - SOM-ORTHO GENERAL OPERATIONS

Schedule: Full-time

Posting Date: Mar 17, 2023

Unposting Date: Ongoing Posting Contact Name: Kathryn Dwyer-Clonts Posting Contact Email: KATHERINE.DWYER-CLONTS@CUANSCHUTZ.EDU Position Number: 00807588





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