<< Back to Search

Clinical Research Services Senior Professional

Job description




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



University of Colorado Denver l Anschutz Medical Campus

School of Medicine, Department of Neurology

Clinical Research Services Senior Professional (Research Services Senior Professional)

Position #754277 - Requisition 14718



The Department of Neurology has an opening for a full-time, University Staff (unclassified) Clinical Research Services Senior Professional (Research Services Senior Professional) position.

The University of Colorado Anschutz Medical Campus ranks among the top institutions nationally in clinical care, education and research. Its 230-acre campus, designed to enhance collaboration and interprofessional education, hosts the College of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; a Health Sciences Library; and two hospitals. Strategically located contiguous to the campus are a biosciences research park and the soon-to-be-completed Veterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees, and five first-professional programs. More than 4,000 students learn alongside faculty members who also make meaningful medical discoveries and provide expert clinical care through 1.5 million patient-visits annually. A hub for research and innovation, CU Anschutz receives over $400 million in research awards each year and has filed 1,300 patent applications and formed 53 new companies since 2002.

Nature of Work:
The Department of Neurology is seeking applications for a Clinical Research Services Senior Professional. This full-time, University Staff position is responsible for executing the logistical planning, procurement and implementation of clinical research studies for the Rocky Mountain Alzheimer's Disease Center (RMADC). Primary duties will include working with the Director of the RMADC to develop resources and processes to support faculty in clinical research development. Additional duties include the logistical planning, procurement and execution of the Rocky Mountain Alzheimer's Disease Center clinical research projects.

Examples of Work Performed:

  • Writing submissions and responses to SARC and COMIRB with the Neurology Regulatory Manager (to include assistance writing informed consent forms, protocols, and other study materials).
  • Writing, preparing, and submitting to the FDA for IND applications or IND waivers with the Neurology Regulatory Manager.
  • Initiating and setting up outside contracts for outsourced services currently not available on campus.
  • Managing the construction of study databases for data collection and analysis. Abstracting and preparing data to be analyzed. Coordinate all data pulls with departmental resources like the biostatistician.
  • Preparing Data Safety Monitoring Board (DSMB) reports.
  • Completing new study feasibility questionnaires and conducting site selection/qualification visits (Business review of study requirements and RMADC center capabilities).
  • Collaborating with and assisting Clinical Research Operations Manager for training new Alzheimer's PRAs, students, or interns. Mentoring new PRAs, students, or interns in Alzheimer's clinical research and assisting in the supervision of the RMADC support staff.
  • Writing and assisting with Alzheimer's Disease Center grant applications and submissions.
  • Collaborating with, overseeing, and maintaining quality assurance for sub-sites (for studies where University of Colorado is the coordinating center or is awarded the grant).
  • Managing the Rocky Mountain Alzheimer's Disease Center clinical trial projects: participating in the study startup and study implementation activities, tracking and reporting study and patient enrollment efforts and statuses, participating in data quality assurance activities, maintaining regulatory documents, assisting Clinical Research Billing Manager for billing questions and study subject payments.
  • Ensuring that all Rocky Mountain Alzheimer's Disease Center clinical trials and research staff working on these trials are consistent with the study protocol, inclusion/exclusion criteria, and research regulations.
  • Assisting in identifying and initiating new funding opportunities and funding proposals.
  • Assisting in budget development, identify resource constraints and prepare milestone achievement reports.
  • Working with Procurement Service Center (PSC) on executing 3rd party vendor contracts.
  • Managing post-award financial activity for studies run through the Rocky Mountain Alzheimer's Disease Center (RMADC). This includes managing multiple funding sources, submitting payments for subject billing, submitting payments through CU Marketplace for study vendors, tracking monthly expenses, and making budget projections.

PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable

Salary and Benefits:

The hiring salary for this position is commensurate with skills and experience. This position is not eligible for overtime.

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: https://www.cu.edu/employee-services/total-compensation

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.

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.

Qualifications

Minimum Qualifications:
  • A Bachelor's degree in a biological science, public health, nursing or directed related field from an accredited institution.
  • Two (2) years of experience working in a clinical research setting.

Preferred Qualifications:
  • A Master's degree in a biological science, public health, nursing or directed related field from an accredited institution.
  • Experience with completing documentations and performing tasks routinely used in clinical trials.
  • ACRP or SoCRA certification as a clinical research coordinator.
  • Experience working with the drug development/approval process and FDA and other clinical research regulations.
  • Experience in the clinical fields of behavioral neurology/aging/dementia/Alzheimer's disease.
  • Experience working with Clinical Trial Management System OnCore.
  • Experience working with Epic and UCD/UCH processes/systems (SARC, UCH submissions, etc.).
  • Experience working with web-based tracking systems and Microsoft Office programs.

Competencies/Knowledge, Skills, and Abilities:
  • Knowledge of the drug development/approval process and FDA and other clinical research regulations.
  • Knowledge of the clinical fields of behavioral neurology/aging/dementia/Alzheimer's disease.
  • Ability to communicate effectively, both in writing and orally.
  • Outstanding customer service and interpersonal skills.
  • Great attention to detail and organizational skills.
  • Work with colleagues and patients in a confidential and professional manner.
  • Must be able to work well within a larger team atmosphere
  • Take initiative to ensure communication, decision-making, and planning among stake-holders and investigators
  • Demonstrated commitment and leadership ability to advance
  • Ability to effectively fulfil the mission and objectives of the Department
  • Ability to prioritize multiple projects on an independent basis and handle changing workloads and assignments as necessary.
  • Demonstrated commitment and leadership ability to advance diversity and inclusion.
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 Office of Equity by email at [email protected] or by phone at (303) 315-2567.

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.

Special Instructions to Applicants:*Applications are accepted electronically ONLY at www.cu.edu/cu-careers. * REQUIRED APPLICATION MATERIALS: 1). A cover letter of application which specifically addresses the job requirements and outlines qualifications. 2). A current resume/CV. 3). List of 3-5 professional references. Questions should be directed to Joshua Schwab at [email protected]

Reference checks are a standard step in our hiring process. You may be asked to provide contact information, including e-mail addresses, for up to 5 references if you are referred to the Hiring Authority for an interview. 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: Review of applications will begin immediately and will continue until the position is filled.



Job Category: Research Services

Primary Location: Aurora

Department: H0001 -- Anschutz Medical Campus - 20244 - SOM-Neurology

Schedule: Full-time

Posting Date: Sep 14, 2018

Closing Date: Ongoing

Posting Contact Name: Joshua Schwab

Posting Contact Email: [email protected]

Position Number: 00754277

PI104415617

 

 

 

Diversity Profile: University

 

Learn more on Inside Higher Ed's College Page for University

Arrow pointing right
Job No:
Posted: 9/16/2018
Application Due: 10/12/2018
Work Type:
Salary: