Clinical Research Coordinator I PRN, Internal Medicine Pulmonary

UT Southwestern Medical Center•Dallas, TX

About The Position

The Clinical Research Coordinator I PRN works under the direction of one or more investigators with general supervision to coordinate research projects. The role primarily coordinates patient and participant involvement, research visits, and data management, while collecting and quality-checking clinical research data for multiple and/or complex studies. The studies support Pulmonary hypertension, Interstitial lung diseases, Lung transplant, Interventional Pulmonology, and COPD, and may involve drugs, devices, or biorepositories. This PRN position provides coverage on an as-needed basis. The coordinator works with clinical research participants by telephone, telehealth, or in person; helps coordinate regulatory and study activities; maintains study documentation; and monitors participant safety and data quality. The position may also support study budgets, billing, protocol development, feasibility reviews, and participant recruitment. Work is performed in clinical and office settings.

Requirements

Bachelor's degree or higher in a medical- or science-related field.
One year of clinical research experience.
Additional years of experience may be considered in lieu of education; an advanced degree may be considered in lieu of experience, respectively.
Knowledge of basic and clinical research terminology, regulations, and procedures.
Strong computer skills, including spreadsheets, databases, and interactive web-based software.
Ability to communicate effectively with various levels of internal and external contacts.
Ability to work with confidential information on a daily basis.
Ability to follow and understand regulations for Protected Health Information (PHI).
Good communication skills and ability to problem solve.
Ability to work proactively to maximize results for the team and organization.

Nice To Haves

ACRP or SOCRA certification is a plus.
BLS Basic Life Support may be required depending on study protocols or affiliate location requirements.
CPR AED may be required depending on study protocols or affiliate location requirements.

Responsibilities

Interact directly with clinical research participants as required, by telephone, telehealth, or in person.
Coordinate regulatory aspects of trials and maintain regulatory information in compliance with industry standards, university policies, FDA requirements, and applicable hospital policies.
Coordinate and schedule study procedures according to protocol; pended order sets may be handled by a non-licensed coordinator with investigator oversight.
When issues arise outside the protocol, present evidence and options to the investigator within the scope of the protocol.
Screen, recruit, enroll, and follow research subjects according to protocol guidelines; assist with the consent process as needed.
Maintain and coordinate study data collection, including developing case report forms or other data collection tools.
Assist in developing and implementing research studies, including writing clinical research protocols.
Conduct study procedures according to protocol after appropriate training and competency check-offs.
Use knowledge of research budgets to assist with or develop study budgets; perform research billing activities as needed, which may include linking patient calendars.
Review and abstract medical-record information to verify trial eligibility as needed.
Monitor patient safety by reviewing records and ensuring reporting follows the protocol and HRPP standards.
Review research protocols for feasibility.
Assist in developing websites or other social media for study marketing and recruitment.
Develop proficiency with the clinical trial management system, electronic medical record, and other required data-entry systems.
Maintain subject-level documentation.
Perform other duties as assigned.

Benefits

PPO medical plan, available day one at no cost for full-time employee-only coverage.
Preventive healthcare coverage at 100% with 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.
On-site childcare.
Paid holidays.
Merit increases.