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
- The Clinical Research Manager is responsible for the implementation and conduct of clinical research trials in the Cancer Clinical Trials Office (CCTO) at the University of Colorado Cancer Center.
- This position is responsible for the 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 being adhered to.
- 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 (i.e. Initial orientations, study audits, closeout visits, physician meetings, research team meetings.) or delegates responsibility to team members as appropriate.
- Participates in preparation for, conduct of and generation of responses to external audits and FDA Inspections, and Data Safety Monitoring audits.
- Collaborates with Data Safety Monitoring Committee, Protocol Review Monitoring Committee, and Oncology Clinical Research Support Team on initiatives.
- Works with budget and regulatory specialist on escalation plans with Contract Research Organizations and Sponsors as needed for resolution of outstanding issues (i.e. financial payment, budget updates, and closeout costs.)
- 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; reviews quarterly finance reports for designated clinical research programs and works with the finance team to resolve discrepancies and review account balances on a regular basis.
- Provides review and corrections to quarterly financial/clinical dashboards.
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)
- Experience working simultaneously with various sponsors and studies in multiple phases.
- Knowledge, Skills, and Abilities Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task.
- Knowledge of research study budgets
- Understanding of computer systems (specifically MS Office Suite)
- 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 managementdata safety monitoringfinancial analysisstudy auditseligibility criteriaoncology researchproblem solvingmulti-tasking
Soft skills
interpersonal communicationorganizational skillsleadershipteam collaborationdelegationmeeting planningauditingquality assuranceadaptabilityattention to detail