Clinical Research Monitoring Project Manager

Job description

Description
University of Colorado | CU Anschutz Medical Campus

School of Medicine – Cancer Center

Clinical Research Monitoring Project Manager

Research Services Manager

Position #00742425 – Requisition #21152

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

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 School of Medicine – Cancer Center has an opening for a full-time University Staff (unclassified) Clinical Research Monitoring Project Manager position.

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 University of Colorado (CU) Cancer Center headquartered at the Anschutz Medical Campus and part of the CU School of Medicine. It is Colorado’s only National Cancer Institute-designated comprehensive cancer center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention and cancer control. CU Cancer Center’s clinical care sites are UCHealth, University of Colorado Hospital and Children’s Hospital Colorado are ranked nationally by U.S. News and World Report.

The CU Cancer Center is a member of the prestigious National Comprehensive Cancer Network®, an alliance of the nation’s leading cancer centers working to establish and deliver the gold standard in cancer clinical guidelines. CU Cancer Center also is a member of the Oncology Research Information Exchange Network (ORIEN), a unique research partnership among North America’s top cancer centers leveraging multiple data sources and matching patients to targeted treatments. CU Cancer Center includes six institutional partners made up of approximately 300 researchers and physicians at three state universities and three healthcare delivery institutions.

The CU Cancer Center’s vision is to “prevent and conquer cancer. Together.” We do this through our mission statement of “uniting our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care and education.”

Job Summary:

This position will serve as a leader in the Oncology Clinical Research Support Team (OCRST) Investigator Initiated Trials (IITs) Program.  This position will be responsible for overseeing clinical data monitoring activities, supervising OCRST monitoring staff and ensuring completion of monitoring tasks.  This position will collaborate with other OCRST team members, sponsor-investigators, clinical research teams, and institutional leadership to ensure patient safety, compliance in protocol conduct, and integrity of data collected.  This position will identify need for and assist in writing policies, procedures or other documentation to support monitoring activities in the CU Cancer Center and throughout UC Denver including contributing to required reports to funding sponsor and DSMC.   The incumbent will lead efforts to establish best practices for multicenter monitoring, source data verification, site evaluations and targeted monitoring methods.                                                           

Examples of Work Performed:

    Assures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Anschutz (CU Anschutz), National Cancer Institute (NCI) and other pertinent regulatory agencies; adheres to CU Cancer Center Standard Operating Procedures,
  • Provides supervision and leadership, oversees orientation and training of OCRST monitoring staff
  • Responsible for assignment and review of OCRST monitoring staff workload
  • Schedules and coordinates the activities of the Monitoring Program for Investigator Initiated and National Clinical Trials Network (NCTN) trials; conducts the monitoring reviews of the trials including issuing data clarification queries as necessary.
  • Writes monitoring reports and communicates monitoring results to OCRST management, teams, including PIs.
  • Manages post-monitoring activities and follow-up on any necessary corrective and preventive actions; escalates findings to OCRST Program Director as necessary.
  • Ensures that written procedures are followed and evaluates quality systems, processes, procedures, and protocols for safety and compliance.
  • Participates in developing SOP’s, guidance documents or other tools/templates pertinent to monitoring activities
  • Assists Cancer Center Principal Investigators in the development of local Investigator Initiated projects by participating in review of protocols for inclusion of relevant data collection and monitoring languageCollaborates with OCRST and other Cancer Center departments and staff to identify and implement ways to improve monitoring practices, procedures, and workflows.
  • Participate in education and training activities for clinical research staff during site initiation visits and identify topics for further educational in-services based on findings and trends noted during monitor visits.
  • Occasional travel within or out of state required for monitoring activities on multicenter IITs.
  • Contributes to funding sponsor, DSMC, PI or other required and requested reports
  • Willingly accepts additional responsibilities and duties as assigned by management. Performs other related duties and procedures, including special projects, as directed.
Salary and Benefits:

The salary range (or hiring range) for this position has been established at $64,455 - $70,000.

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 ineligible 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 [email protected].

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
Minimum Qualifications:

    Bachelor’s degree in science, nursing, health, public health or other related discipline
    Five (5) years of clinical research experience including at least two (2) years’ experience with clinical data monitoring. NOTE: For this position, monitoring is defined as a quality control function that ensures the protection of research subjects, verifies the completeness and accuracy of trial data and establishes that the trial was conducted in accordance with the protocol, GCP, and pertinent regulations at the clinical trial site in real time.
One (1) year personnel management experienceSubstitution: Relevant work experience can substitute for the bachelor’s degree on a year-to-year basis.

Preferred Qualifications:

    Quality Assurance, Quality Control or Monitoring experienceThree years’ clinical research experienceOncology research experienceExperience working with investigator-initiated researchExperience working in an academic settingUnderstanding of industry trends (Risk Based Monitoring, Remote Monitoring, Remote Source Data Verification/Review, etc.)
Competencies/Knowledge, Skills, and Abilities:

    Ability to problem solve and multi-task Excellent computer skills. Proficient in Windows, MS Word, ExcelPossesses advanced knowledge of ICH GCP Guidelines, FDA Rules and Regulations, NIH guidelines, and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions.Possesses an understanding of the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with NCI sponsored, private industry and investigator initiated clinical trials.Knowledge of basic human anatomy, physiology, medical terminologyAbility to communicate effectively and with a high level of professionalism across various stakeholders


Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: May 5, 2021
Unposting Date: Ongoing

 

 

 

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Job No:
Posted: 5/7/2021
Application Due: 6/9/2021
Work Type: Full Time
Salary: