Description
University of Colorado Anschutz Medical Campus

OCRST Clinical Research Project Coordinator (Open Rank)

Research Services Professional (Sr. Professional, Principal Professional)

Cancer Center

Position: 708533 Requisition 22257

***THIS POSITION IS PRIMARILY REMOTE***

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.”

This position will participate as a member of the Cancer Center’s Oncology Clinical Research Support Team (OCRST) in the development and implementation of Investigator Initiated research trials. This position will participate in writing and review of Investigator Initiated Trial (IIT) protocols, develop study tools such as PI oversight plan, laboratory manuals, and other instructional tools that are needed to support the implementation and ongoing maintenance of IITs.   This position works closely with clinical research teams to operationalize IITs, but is not responsible for patient recruitment to clinical research projects.  Performs tasks related to multicenter trial coordination including site feasibility evaluations, hosting teleconferences, and performing registration/randomization activities. 

Examples of Work Performed:

These job descriptions have been designed to indicate the general nature and level of work performed by employees within its classification. It is not designed to contain or be interpreted as comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Project Coordinator Level I Duties (Senior Professional)

Assists Cancer Center principal investigators in the development of local Investigator Initiated protocols by providing clinical and operational expertise as well as review for consistency of eventsResponsible for assisting principal investigators in the development of the protocol and subsequent amendments for Investigator Initiated Trials to ensure standardization and adherence to University and Cancer Center, FDA and GCP policies and guidelines for investigator initiated and multi-center trials
• Works closely with the clinical research managers and staff in the areas where the trials will take place to ensure study as written is feasible for the disease site team; maintains processes that allow smooth transition of study to disease team once open. Perform initial submission of IITs to Protocol Review and Monitoring System (PRMS) and Human Subjects Research (HSR) Portal.
• Serves as primary contact for trials assigned and as such will be responsible for developing a communication plan as well as trial study manuals, lab manuals and other instructional tools for the clinic teams.
• Performs administrative and oversight tasks for all participating institutions which may include registration and randomization activities, coordinating regular teleconferences with all participating institutions, compiling data for reporting to DSMC or other regulatory or oversight entity.
• Communicates with Finance Professional and Contracts Associate to ensure budget and contract progress in line with other study activation activities; escalate as necessary to PI and/or OCRST Program Director.
• Works with PI and data specialist on development of electronic case report forms for trials utilizing OnCore,  REDCap or Advarra databases
• Delegates and oversees tasks related to Investigator Initiated Trials Program as appropriate to Program support staff or data specialist.
• Participates in activities related to development of best practices as related to conduct of IITs and multi-center trials.
• Facilitate site evaluation and feasibility assessments for multi-center Investigator Initiated Trials

Project Coordinator II Duties (Senior Professional)

Adheres to and conducts all duties related to the Project Coordination Level I.
• Independently manages and provides support for more complex Investigator Initiated Trials (i.e. multi-site and Phase I trials) with a commitment to providing a high level of customer service.
• Recommends and drafts enhancements to SOP’s, guidance documents or other tools/templates pertinent to project coordination activities.
• Assists Clinical Research Project Manager with resolving issues by utilizing independent judgement, discretion, creativity and analytical thinking.
Participates in activities related to training of clinical trial team staff on topics identified during communications, monitor visits and audits.Participates in onboarding and training activities for new members of the Project Coordinator team; serves as back up coverage during team absences. Follow up and track all operational activities related to the above to ensure activities and deliverables are being executed according to agreed upon timelines.

Project Coordinator III Duties (Principal Professional)

Adheres to and conducts all duties related to the Project Coordinator Level I and II.Acts as mentor to and participates in planning for and onboarding activities for new members of the Project Coordinator team; serves as back up coverage during team absences.Prepare meeting presentations and/or deliver trainings during meetingsIndependently drafts proposals for enhancements to SOP’s, guidance documents or other tools/templates pertinent to project coordination activities Takes on special projects for team development (i.e. meeting with collaborators to refine/expand processes, development of new workflows, etc.)Assists Clinical Research Project Manager in defining areas for improvement around protocol development, data analysis, etc.

Salary and Benefits:

The starting salary range for a Level I Project Coordinator is $50,388 and is commensurate with skills and experience.

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 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: 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 hr.adacoordinator@ucdenver.edu.

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
Project Coordinator Level I Requirements

Education:  BS or BA in Biology, Chemistry, Behavioral Science, Science, Health, Nursing or other related discipline.

Experience:  A minimum of 2 years clinical research experience.

Substitution:  A combination of education and clinical research or project coordination experience can substitute for the degree on a year for year basis.

Preferred Qualifications:

• Three or more years of research experience in an academic setting
• One year experience with investigator initiated multi-center studies
• Experience operationalizing clinical research studies
• Prior oncology experience

Project Coordinator II Requirements

Education:  BS or BA in Biology, Chemistry, Behavioral Science, Science, Health, Nursing or other related discipline.

Experience: Three (3) years of clinical research experience including at least two years of experience with project coordination of clinical trials.  For this position, project coordination is defined as management of the clinical research projects and activities to ensure compliance with protocols and overall clinical objectives. This will include directing all aspects of clinical trial team activities for assigned projects with respect to site selection, project plans and tools, trial budget and timeline management, data collection and analysis, quality standards and risk mitigation.  

Substitution:  A combination of education and clinical research or project coordination experience can substitute for the degree on a year for year basis.

Preferred Qualifications:

Understanding of medical terminology and technical writing experienceOncology research experienceExperience working with investigator initiated researchExperience working in an academic settingThorough knowledge of ICH/FDA guidelinesCurrent Clinical Research Certification (CCRC, CCRA, CCRP) or meets criteria to sit for exam within one year

Project Coordinator III Requirements

Education:  BS or BA in Biology, Chemistry, Behavioral Science, Science, Health, Nursing or other related discipline.

Experience: Four years of clinical research experience including at least three years of experience with project coordination of clinical trials.  For this position, project coordination is defined as management of the clinical research projects and activities to ensure compliance with protocols and overall clinical objectives. This will include directing all aspects of clinical trial team activities for assigned projects with respect to site selection, project plans and tools, trial budget and timeline management, data collection and analysis, quality standards and risk mitigation.  

Substitution:  A combination of education and clinical research or project coordination experience can substitute for the degree on a year for year basis.

ACRP, SOCRA or RAC certification is required.

Preferred Qualifications:

Understanding of medical terminology and technical writing experiencePrevious mentoring experienceOncology research experienceExperience working with investigator initiated researchExperience working in an academic settingThorough knowledge of ICH/FDA guidelines

Knowledge, Skills and Abilities (for all levels):

• Ability to problem solve and multi-task.
• 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.Proficient in writing or creating documentation such as SOPs, guidance documents or other similar documents

Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Nov 17, 2021
Unposting Date: Ongoing