Clinical Research Coordinator I, Pediatric Cystic Fibrosis

UT Southwestern Medical Center • Dallas, TX

12h • Onsite

About The Position

This position works under the direction of an Investigator(s) with general supervision to coordinate research projects. The role primarily performs patient/participant coordination and may conduct data management in smaller departments on an as-needed basis. The coordinator collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies. Responsibilities include maintaining databases, completing data abstraction and queries, performing necessary tasks in the ECRF platform, preparing for study visits, screening patients for study eligibility, supporting the CF plus team in building redcap projects, and assisting in ensuring studies remain compliant with all regulatory requirements.

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 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.
• Pends approved study protocols which have order sets built by the non-licensed coordinator with oversight by PI.
• Presents evidence and provides options (within scope of protocol) to PI when outside of protocol.
• Screen, recruit, enroll and follow subjects according to protocol guidelines.
• 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.
• Assist with or develop study budgets, requiring familiarity with research budgets.
• Perform research billing activities, as needed, based on size of department (including linking patient calendars).
• 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.
• Perform duties that 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% 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