Lead Clinical Research Coordinator, Neurology

UT Southwestern Medical Center • Dallas, TX

58d

About The Position

Works 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.

Requirements

• Bachelor's Degree in medical or science related field
• 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.

Nice To Haves

• (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.
• Active phlebotomy License or Certification
• Bi-Lingual in English and Spanish
• Previous experience in a clinical research environment working with geriatric patients

Responsibilities

• 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.

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: Mid Level
• Number of Employees: 5,001-10,000 employees