Clinical Research Monitoring Project Manager
University of Colorado | CU Anschutz Medical Campus
- 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.
Total Compensation Calculator: http://www.cu.edu/node/153125Diversity 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.
- 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.
- 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.)
- 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
Posting Date: May 5, 2021
Unposting Date: Ongoing