What are the responsibilities and job description for the Senior Clinical Research Coordinator - Cancer Center (MCA) position at University of Kansas Medical Center?
Description
Job Duties Outlined :
Under the direction of the KUCC-MCA MU NCORP principal investigator evaluate potential patient eligibility for clinical trials.
Assist MCA clinical staff with maintaining source documents and submit electronic case report forms (CRFs) as required for clinical trials.
Assure that clinical trial is conducted in accordance with all KUMC and other regulatory requirements.
Recognize and report adverse events / serious adverse events to the Principal Investigator, FDA, and sponsors.
Assist clinical staff with understanding study procedures, as outlined in the protocol, reporting protocol deviations and developing corrective and preventive plans as needed.
Prepare documents for distribution to MCA sites regarding eligibility and training for new trials.
Assist clinical staff with understanding study procedures, as outlined in the protocol, reporting protocol deviations and developing corrective and preventive plans as needed.
Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
Attend continuing education, research and training seminars as requested by manager, including KUCC disease working group meetings and national NCTN meetings.
Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
As requested, facilitate monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures.
Assesses feasibility of research protocol including appropriate patient population, budget and specific needs for the study if inclusion of MCA sites.
Assist Principal Investigators with internal and external funding application submissions.
Required Qualifications
Education : Associate’s degree plus six years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals at least 8 years.
Certification : Research certification required such as Socra, Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP).
Work Experience :
Demonstrated advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA).
Demonstrated advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
In-depth knowledge of study budgets, contracts, and grant applications.
Preferred Qualifications
Education : Master’s degree in relevant field.
Skills :
Ability to fully contribute to multidisciplinary teams including physicians, administrative staff.
Demonstrated ability to work independently.
Superb attention to detail, organizational, and time management skills as evidenced by application materials.
Excellent communication as evidenced by application materials.
Experience using computer MSO Suite : Outlook, Windows, Excel and Word.
Required Documents : Resume / CV
Cover Letter
Comprehensive Benefits Package :
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.
Employee Type : Regular
Time Type : Full time
Rate Type : Salary
Compensation Statement :
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range :
65,000.00 - $99,000.00
Minimum
65,000.00
Midpoint
82,000.00
Maximum
99,000.00
Salary : $65,000 - $99,000
