Clinical Research Manager – GI, GU, Sarcoma
Oracle
Clinical Research Manager – GI/GU/Sarcoma
Oracle
full-time
Posted on:
Location Type: Hybrid
Location: Aurora • Colorado • 🇺🇸 United States
Visit company websiteSalary
💰 $71,244 - $90,622 per year
Job Level
Mid-LevelSenior
About the role
- Responsible for the implementation and conduct of clinical research trials in the Cancer Clinical Trials Office (CCTO)
- Oversight of all clinical studies and research staff in assigned programs
- Oversees 1 to 3 different disease sites at a given time
- Manages all staff updates in prescribed databases
- Manages all Protocol Amendments for disease sites and disseminates changes to team (budget, regulatory, and UCH team members) and updates prescribed databases
- Promotes quality study flow and ensures all governing regulations are adhered to
- Reviews Medicare Analysis reviews for each new Amendment for applicable disease sites
- Acts as an interdepartmental liaison with UCH clinic staff (incl. investigators, nurses, clinic support staff, laboratory, pharmacy, radiology)
- Plans and directs investigator and coordinator meetings or delegates responsibility to team members as appropriate
- Works with budget and regulatory specialist on escalation plans with Contract Research Organizations and Sponsors as needed for resolution of outstanding issues
- Oversees team schemas as studies are amended for eligibility, cohort changes, additional arms added, and study closeout
- Participates in cost savings/productivity strategies to meet or improve the department's operational budget
- Provides review and corrections to quarterly financial/clinical dashboards
- Participates in preparation for, conduct of and generation of responses to external audits and FDA Inspections
- Collaborates with Data Safety Monitoring Committee, Protocol Review Monitoring Committee, and Oncology Clinical Research Support Team
- Works with the Oncology Clinical Research Support Team staff on Investigator Initiated Trials reviewing protocol, amendment changes, and clinical toolkit
- Assists investigators with miscellaneous tasks as applicable
Requirements
- Bachelor’s degree with a preferred emphasis in business, health administration, communications, biological or social science, or any other field of study related to the work assignment
- Five (5) years’ clinical research experience
- Two (2) years’ clinical research or health care personnel management experience (can be included in above clinical research experience or can be from another healthcare related position)
- Oncology experience (clinical or research) preferred
- Experience working simultaneously with various sponsors and studies in multiple phases preferred.
- Experience working in an academic medical setting preferred.
- Experience in teaching, precepting and mentoring employees to clinical research preferred.
- Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task.
- Understands 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 research study budgets
- Understanding of computer systems (specifically MS Office Suite) and ability to work efficiently within various applications.
- Knowledge of Good Clinical Practices, 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.
- Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology
- Ability to learn, interpret and master complex protocol information.
Benefits
- Medical: Multiple plan options
- Dental: Multiple plan options
- Additional Insurance: Disability, Life, Vision
- Retirement 401(a) Plan: Employer contributes 10% of your gross pay
- Paid Time Off: Accruals over the year
- Vacation Days: 22/year (maximum accrual 352 hours)
- Sick Days: 15/year (unlimited maximum accrual)
- Holiday Days: 10/year
- Tuition Benefit: Employees have access to this benefit on all CU campuses
- ECO Pass: Reduced rate RTD Bus and light rail service
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchprotocol amendmentsbudget managementregulatory complianceclinical trial phasesGood Clinical PracticesFDA regulationsNIH guidelinesICH guidelinesmedical terminology
Soft skills
interpersonal communicationorganizational skillsproblem solvingmulti-taskingteachingpreceptingmentoring