Clinical Research Coordinator II, Pediatrics

UT Southwestern Medical Center • Dallas, TX

1d

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 clinical or basic research data in support of multiple and/or complex research studies.

The Clinical Research Coordinator II will serve as the foundational team member in the growing, translational Center for Inborn Errors of Immunity. Reporting directly to the Principal Investigator, the CRC II will take on a diverse set of responsibilities in true translational research that spans bench and clinical research. Key responsibilities include IRB protocol development and maintenance, patient recruitment and enrollment, clinical visit coordination, sample collection and delivery to sample processing site. Experience in regulatory submissions, IRB protocols, and study start-up. Phlebotomy, sample handling, and biobanking. REDCap proficiency required; experience with Epic and Microsoft Office strongly preferred. Familiarity with data analysis or visualization tools such as R, Stata, SAS, GraphPad Prism, or SPSS is a plus. Ability to work independently and across teams. ACRP or SOCRA certification required (or obtained within the first 6 months of hire).

Requirements

• Bachelor's Degree in medical or science related field
• 2 years clinical research experience.
• May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
• Experience in regulatory submissions, IRB protocols, and study start-up.
• Phlebotomy, sample handling, and biobanking.
• REDCap proficiency required

Nice To Haves

• Experience with Epic and Microsoft Office strongly preferred.
• Familiarity with data analysis or visualization tools such as R, Stata, SAS, GraphPad Prism, or SPSS is a plus.
• Ability to work independently and across teams.
• ACRP or SOCRA certification a plus.

Responsibilities

• 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 assist the PI on the fiscal management of the trial including budget preparation.
• Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
• May perform research billing activities, as needed, based on size of department (including linking patient calendars).
• Coordinates data management and collection for national (larger/more complex) research studies or multiple research studies at a given time.
• Serves as primary liaison/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.
• 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 or assists in assembling data to enter in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
• Maintains required subject documentation for each study protocol.
• 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