Clinical Research Coordinator I, Cancer Center

UT Southwestern Medical Center • Dallas, TX

10h

About The Position

Works under the direction of an Investigator(s) with general supervision, to coordinate research projects. This position primarily performs patient/participant coordination, however, may conduct data management in smaller departments on as needed basis. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies.
The Clinical Research Coordinator will assist with data queries and possible edits for accuracy, maintain existing databases and ensure data integrity, and assists research staff by completing research protocol related tasks. The Clinical Research Coordinator should have a firm understanding of visit schedules, criteria and protocol requirements for routine and low complexity trials (e.g., questionnaire, data registry, scripted); and scheduling research visits. The Clinical Research Coordinator will screen, recruit, enroll and follow subjects according to protocol guidelines. They may also assist with the consent process. Maintain and coordinate data collection information required for each study which may also include developing CRF's or data collection tools. Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order.

Requirements

• Bachelor's Degree or higher degree in medical or science related field
• 1 year of clinical research experience
• May consider additional years of experience or advanced degree in lieu of education or experience, respectively.

Nice To Haves

• (BLS) BASIC LIFE SUPPORT Licensure may be required based on research study protocols or affiliate location requirements.
• (CPRAED) CPR AED Licensure may be required based on research study protocols or affiliate location requirements.
• ACRP or SOCRA certification a plus

Responsibilities

• Directly interacts with clinical research participants, as required, for the research study. Interacts via telephone, telehealth or in-person.
• Coordinate regulatory aspects of the trial including maintaining and developing regulatory information to comply with industry standards, University policies, FDA requirements or other hospital policies
• Coordinate and schedule study procedures as per protocol. Approved study protocols which have order sets built may be pended by the non-licensed coordinator with oversight by PI.
• When outside of protocol, presents evidence and provides options (within scope of protocol) to PI.
• Screen, recruit, enroll and follow subjects according to protocol guidelines. May also assist with the consent process
• Maintain and coordinate data collection information required for each study which may also include developing CRF's or data collection tools
• Assist in developing and implementing research studies to include writing clinical research protocols.
• Conduct study procedures according to the protocol with proper training and check offs to maintain scope of work
• Requires familiarity with research budgets to assist with or develop study budgets. May perform research billing activities, as needed, based on size of department (including linking patient calendars).
• May review and abstract information from medical records for verification of eligibility for trials, as needed based on size of department.
• Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
• Review research study protocols to ensure feasibility
• Assist in developing website or other social media for marketing/recruiting of clinical research study
• Develop proficiency in the clinical trial management system, electronic medical record and other required data entry systems
• Maintain subject level documentation
• Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
• Performs other duties as assigned.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100%25 coverage for preventive healthcare-no copay
• Paid Time Off, available day one
• Retirement Programs through the Teacher Retirement System of Texas (TRS)
• Paid Parental Leave Benefit
• Wellness programs
• Tuition Reimbursement
• Public Service Loan Forgiveness (PSLF) Qualified Employer

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees