Clinical Research Coordinator II - Orthopaedic Surgery Department

Job Summary

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.

Experience and Education

• Bachelor's degree in medical or science related field and two years clinical research experience.
• May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
• ACRP or SOCRA certification a plus.
• A Heart Saver for non-licensure or BLS for Licensure may be required based on research study protocols or affiliate location requirements.

Job Duties

May perform some or all the following:

• 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.

Knowledge, Skills & Abilities

• Work requires knowledge of basic and clinical research terminology, regulations, and procedures.
• Work requires strong computer skills (spreadsheets, databases, and interactive web-based software).
• Work requires ability to communicate effectively with various levels of internal and external contacts.
• Work requires ability to work with confidential information on daily basis
• Proactively works to maximize results of the team and organization
• Follows and understands the regulations for Protected Health Information (PHI)
• Work requires good communication skills.
• Work requires the ability to problem solve.

This position is security-sensitive and subject to Texas Education Code •51.215, which authorizes UT Southwestern to obtain criminal history record information.
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.