JOB SUMMARYWorks under the direction of an Investigator(s) with limited 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 research data in support of multiple and/or complex research studies.
The Clinical Research Coordinator Lead provides operational leadership and oversight for a portfolio of transplant surgery clinical trials, with a primary focus on industry-sponsored and investigator-initiated IND drug infusion studies. This position guides study start-up activities, regulatory submissions, participant enrollment, protocol implementation, and ongoing study management to ensure compliance. The Lead may provide supervision and coordination of the activities of transplant surgery research coordinators, providing mentorship, training, and oversight to promote high-quality and efficient study conduct. Responsibilities include assisting with study feasibility assessments, budget development, contract review, resource allocation, data quality monitoring, and audit preparedness.
BENEFITSUT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
- 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
- Learn more about these and other UTSW employee benefits!
EXPERIENCE AND EDUCATIONRequired- Education
Bachelor's Degree in medical or science related field
- Experience
4 years of clinical research experience with Bachelor's Degree
Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience.
May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
Preferred- Licenses and Certifications
(BLS) BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements.
(CPRAED) CPR AED may be required based on research study protocols or affiliate location requirements.
ACRP of SOCRA certification a plus.
JOB DUTIES- Maintains required subject documentation for each study protocol.
- Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person.
- Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.
- Coordinates and schedules procedures as per research study. A non-licensed coordinator may pend study order sets with oversight by PI.
- Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures). May also assist with the consent processes.
- Maintains and coordinates data collection information required for each study that may also include developing CRF's (case report form) or data collection tools.
- Assists in developing and implementing research studies, may include writing clinical research protocols.
- Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.
- May provide supervision to other members of the research team as necessary.
- May perform research billing activities, as needed, based on size of department (including linking patient calendars
- Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
- Assists PI/supervisor with daily activities of the research team and functions as a liaison between clinical research investigators and various organizations/departments and agencies including, but not limited to HRPP, FDA, Sponsored Programs, and affiliated hospitals.
- Coordinates data management and collection for national (larger/more complex) research studies.
- Serves as lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.
- Prepares protocols for Institutional Review Board (IRB) submission. May also submit amendments and continuing review documents.
- Assists and monitors and/or maintain research study budgets. Assists the PI with the fiscal management of the trial. Ensures that the patient care charges are allocated appropriately for various research studies.
- Provides in-service training to all study team members and communicates to involved groups.
- Reviews research study protocols to ensure feasibility requirements of the study.
- Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study.
- Enters data in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
- 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.
