Clinical Research Coordinator II

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 supports and coordinates a wide range of clinical research activities to ensure compliance with study protocols, regulatory requirements, and institutional guidelines. This role is responsible for maintaining accurate documentation of clinical research activities, including site communications, correspondence, inventory records, and study-related documentation.
Key responsibilities include coordinating and managing clinical trial supplies, tracking shipments to study sites and warehouses, and overseeing vendor relationships related to trial materials. The coordinator assists with the collection, processing, labeling, storage, and shipment of biological specimens, including blood, urine, tissue, and other samples, in accordance with study protocols and local, federal, and IATA regulations. Additional duties include reconciling shipment billing, coordinating sample procurement, maintaining specimen integrity, and ensuring timely distribution to clinical and research laboratories. The Clinical Research Coordinator II may also train laboratory staff on research techniques, procedures, and equipment, assist principal investigators and research teams with the preparation of reports, manuscripts, and publications, and perform other research-related duties as assigned.

Requirements

• Bachelor's Degree in medical or science related field
• 2 years years clinical research experience.
• May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
• Exceptional, established experience coordinating clinical research studies involving human participants
• Strong written and verbal communication skills with the ability to collaborate effectively across multidisciplinary teams
• Experience using REDCap and Epic systems
• Comfort handling and processing biological specimens, including bodily fluids and tissue samples
• Strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced research environment

Nice To Haves

• Knowledge of clinical research regulations, study protocols, and specimen handling best practices preferred
• (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 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