Clinical Research Monitor

Job description




University of Colorado Anschutz Medical Campus

School of Medicine, Cancer Center

Research Services Senior Professional (OCRST Research Monitor)

Position #756802 - Requisition #14536

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

The University of Colorado Denver l 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 Cancer Center has an opening for a full-time University Staff (unclassified) Research Services Senior Professional (OCRST Research Monitor) 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 Cancer Center, located at the Anschutz Medical Campus, 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 partner for adult care, University of Colorado Hospital is ranked in the top 15 hospitals nationwide by U.S. News and World Report and Children's Hospital Colorado is ranked 8th by the same organization in Pediatric Cancer Care. 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 is a consortium of approximately 261 researchers and physicians at three state universities and three clinical institutions, all working toward its vision to prevent and cure cancer while being a global model for patient care delivery, interdisciplinary research, and training.

This position will assist with the implementation and coordination of the Oncology Clinical Research Support Team (OCRST) Investigator Initiated Trials (IITs) Program at the University of Colorado Cancer Center by participating in protocol development and data monitoring activities. This position will collaborate with other OCRST members, sponsor-investigators and clinical research teams to ensure compliance in protocol conduct, patient safety and data integrity for IITs assigned. Data monitoring will include verification of the accuracy, completeness, validity & integrity of all data collected. This position will identify need for and assist in writing policies, procedures or other documentation to support monitoring activities in the Cancer Center.

Examples of Work Performed:

  • Ensures 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 Denver (UCD), National Cancer Institute (NCI) and other pertinent regulatory agencies, plus adheres to institution Standard Operating Procedures,
  • Schedules and coordinates the activities of the Monitoring Program for Investigator Initiated and National Clinical Trials Network 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 and forwards results to DSMC for review.
  • Manages post-monitoring activities and follow-up on any necessary corrective and preventive actions; escalates unacceptable findings to OCRST Monitoring Manager and Program Director as appropriate.
  • 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 monitoring language
  • Collaborates with OCRST and other Cancer Center departments and staff to identify and implement ways to improve monitoring practices, procedures, and workflows.
  • Works with the education and development coordinator, as well as the sponsor-investigators on training of CRC and data management staff during site initiation visits and based on topics noted from monitor visits.
  • Occasional travel within or out of state required for monitoring activities on multicenter IITs.


This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Salary and Benefits:

Salary is commensurate with skills and experience.

This position is not eligible 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: https://www.cu.edu/employee-services/total-compensation

Diversity and Equity:

Please click here for information on disability accommodations: http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx

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:

Education: Bachelor's degree in science, nursing, health, public health or other related discipline.

Experience:
  • Two years of clinical research experience.
  • Experience with monitoring clinical trials. 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.


Substitution: Clinical research or monitoring experience can substitute for the degree on a year for year basis.

Preferred Qualifications:
  • Quality Assurance, Quality Control or Monitoring experience
  • Three or more years of clinical research experience
  • Oncology research experience
  • Experience working with investigator initiated research
  • Experience working in an academic setting


Knowledge, Skills and Abilities:

  • Ability to problem solve and manage multiple priorities and deadlines.
  • Excellent computer skills. Proficient in Windows, MS Word, Excel.
  • Possesses knowledge of Good Clinical Practices Manual, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH 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 terminology.
  • Ability to communicate effectively and with a high level of professionalism across various stakeholders.



Special Instructions to Applicants:Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references) Questions should be directed to: [email protected]



Application Materials Required:Cover Letter, Resume/CV, List of References

Application Materials Instructions:Application Deadline: Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Applications will be accepted until finalists are identified, but preference will be given to complete applications received by December 24, 2018. Those who do not apply by December 24, 2018 may or may not be considered.



Job Category: Research Services

Primary Location: Aurora

Department: H0001 -- Anschutz Medical Campus - 20066 - SOM-U of Colo Cancer Center

Schedule: Full-time

Posting Date: Dec 14, 2018

Closing Date: Ongoing

Posting Contact Name: Amanda Beyer-Purvis

Posting Contact Email: [email protected]

Position Number: 00756802

PI106277389

 

 

 

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Job No:
Posted: 12/15/2018
Application Due: 2/13/2019
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