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Investigator-Initiated Clinical Research Specialist

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

Investigator-Initiated Clinical Research Specialist (Research Services Principal Professional)

Position #755281 - Requisition 14966



The Department of Neurology has an opening for a full-time, University Staff (unclassified) Investigator-Initiated Clinical Research Specialist (Research Services Principal 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. Read CU Anschutz Quick Facts here.

Nature of Work:
This role will act as a subject matter expert and will be responsible for executing the logistical planning, procurement and implementation of investigator initiated clinical research studies for the Department of Neurology. Primary duties will include working with the Management team to develop resources and processes to support faculty in clinical research investigator initiated study development. The Neurology Clinical Research team has more than 100 clinical studies, many of which use and administer patient-reported outcomes for the studies. This position will be the primary contact for all PROs within the department and will work with investigators to develop and administer new ones. This position will work closely with the IT team to make the process more efficient and streamlined to ease the burden of collecting paper documents.

Examples of Work Performed:

  • Logistical planning, procurement and execution of the Department of Neurology's investigator initiated clinical research projects.
  • Coordination of regular study meetings, including annual investigators' meeting and stakeholder meetings. To include administrative tasks: securing a date and location for the meeting and detailed logistics of the meeting (food, lodging, meeting space, etc.). Clearly communicate meeting agenda and information to study staff at all participating sites.
  • Attend and prepare for the trial's annual PI and coordinator's meeting each year (in addition to mentioned tasks above: prepare information for meeting to be discussed with all participants).
  • Assist the PI in developing the protocol and operations manual for the study and subsequent amendments.
  • Monitor enrolling site performance for subject accession and data acquisition in accordance with the protocol and convey this information to the PI on a regular basis.
  • Provide leadership and training to external sites implementing the study protocol. Utilize positive team building skills with study team members. Maintain professional verbal and written communications. Provide input and directions for study quality improvement activities
  • Develop and serially improve training materials and trial protocols for site coordinator activities.
  • Supervise study interactions and implementation in all external sites. Ensure proper regulatory approvals are in place at each site. Understand and document all site standard practices and capabilities as they impact study implementation. Identify, cultivate and support study champions among nursing, physician and administrative staff at each site.
  • Serve as lead contact for all external and internal site investigator physicians and study coordinators as expert on the study and the study protocol. Provide protocol clarifications on a daily basis via telephone, fax, email, and surface mail.
  • Serve as backup coordinator to the study coordinator.
  • Coordinate and manage data quality monitoring as well as any required SARC and DSMB requirements.
  • Coordinate any protocol changes with the PI and IRB to make sure that changes are implemented and executed appropriately.
  • Manage the development of all source documents to ensure consistency across all sites.
  • Monitor UC Denver site for data quality. To include spot checking patient visits, review all visits are being performed in accordance to research regulations, department SOPs, protocol, Good Clinical Practice, and good documentation practices for all visits.
  • Manage post-award activity for investigator initiated studies that includes overseeing multiple funding sources, tracking monthly expenses, and making budget projections.
  • Along with study coordinator, maintain study regulatory binder including current and past study documents, staff credentials, and training and delegation logs.

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 commemorate 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 public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
  • Four (4) years of professional level experience working on clinical research projects.

Preferred Qualifications
  • Experience working with Neurology clinical trials.
  • Master's degree in a biological science or public health or nursing or equivalent from an accredited institution.
  • Experience completing documentations and performing tasks routinely used in clinical trials.
  • ACRP or SoCRA certification.
  • Experience working with drug development/approval process, including FDA and other clinical research regulations.
  • Experience working with Clinical Trial Management System OnCore.
  • Experience working with Epic and UCD/UCH processes/systems (SARC, UCH submissions, etc.).
  • Experience with web-based tracking systems and Microsoft Office programs.

Competencies/Knowledge, Skills, and Abilities
  • 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.

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 Shelby Potter 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: Applications will be accepted until the position is filled, but full consideration will be given to complete applications received by October 31, 2018. Those who do not apply by October 31, 2018 may or may not be considered.



Job Category: Research Services

Primary Location: Aurora

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

Schedule: Full-time

Posting Date: Nov 27, 2018

Closing Date: Ongoing

Posting Contact Name: Shelby Potter

Posting Contact Email: [email protected]

Position Number: 00755281

PI105845306

 

 

 

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Job No:
Posted: 11/28/2018
Application Due: 1/27/2019
Work Type:
Salary: