Clinical Research Coordinator I, Pediatrics Allergy and Immunology

UT Southwestern Medical Center • Dallas, TX

16h

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.
In addition to Clinical Research Coordinator duties this person will help with regulatory compliance, database maintenance, and collaborate with other institutions and Sponsors.

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

• Strong clinical research regulatory experience in an academic medical center or clinical research site environment
• Demonstrated experience preparing and submitting IRB applications, amendments, continuing reviews, and reportable events in accordance with institutional and federal requirements.
• Experience supporting study start-up activities, prepare and submit initial IRB packages and regulatory documentation required for study activation
• Coordinate with sponsors, CROs, and institutional departments to ensure timely study start-up and site activation.
• Support development of study documents including consent forms, recruitment materials, and protocol-specific regulatory submissions
• (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