Lead Clinical Research Assistant - Otolaryngology Department

Departmental Job Description

The Otolaryngology Department is looking to hire a full time Lead Clinical Research Assistant to assist with ongoing clinical research studies. The employee works under the direction of an Investigator(s) with limited supervision, to provide ongoing data management for local and national research studies and may coordinate observational (non-treatment/treatment) trials/studies. The employee will also work on complex studies in a lead role, under the direction of the PI and/or Clinical Research Coordinator.

Experience and Education

• High School and 4 years of experience, or Associate's degree in medical or science related field and 2 years of experience, or Bachelor's degree or higher degree in medical or science related field and one year prior research experience.
• May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
• A minimum of Heart Saver for non-licensure or BLS for Licensure may be required based on research study protocol or affiliate location requirements.

Job Duties

May perform some or all of the following based on research study:

• Knowledge, Skills & Abilities Knowledge of applicable Federal and institutional regulations gAssists with participant screening and recruitment for complex trials or multiple research studies at any given time.
• Conducts and documents consent for participants in studies.
• Develops consent plans and documents for participants.
• Independently corrects and documents incomplete, inaccurate, or missing data for more complex studies.
• Understands visit schedules, inclusion/exclusion criteria and protocol requirements for complex trials; schedules research visits, etc.
• Completes research protocol related tasks.
• Reviews and abstracts information from medical records including eligibility criteria.
• Recruits and enrolls patients in research study that may include consenting patients.
• Enters data into case report forms or other data collection system based on research study.
• Assists with maintenance of study level documentation.
• Assists with data queries and possible edits for accuracy.
• Compiles data for regulatory requirements and /or deadlines for local or sponsor submissions.
• Maintains existing databases and ensures data integrity.
• Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order.
• Assists with collecting and processing specimens following established procedures/protocols.
• With adequate training/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKG's needed for research study.
• Based on research study, other procedures/equipment/services may be required. May perform patient care (basic skills) under the direction of PI following scope of work document.
• 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.
• May provide working supervision or direction of lower level Clinical Research Assistants.
• Performs QA/QC clinical analysis and data checks using various databases based on trial.
• Assists with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO).
• Assist and prepare research records for formal sponsor audits or internal audits.

Knowledge, Skills, and Abilities

• Knowledge of clinical research protocols.
• Effective organizational skills and attention to detail.
• Proactively works to maximize results of the team and organization.
• Follows and understands the regulations for Protected Health Information (PHI).
• Proactively works to maximize results of the team and organization.
• Possess strong computer skills (spreadsheets, databases, and interactive web-based software).
• Possess good communication skills.
• Possess the ability to problem solve.
• Work requires ability to conduct interviews with research subjects.

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.

To learn more, please visit: https://jobs.utsouthwestern.edu/why-work-here/diversity-inclusion