Clinical Research Assistant I, Department of Ophthalmology

This position will be 100% On Site / In-Person

Departmental Job Description

The Ophthalmology Department is seeking a qualified candidate for the role of Clinical Research Assistant I in the Clinical Research Unit. The key responsibilities of this position include coordinating research studies and trials, performing protocol-related procedures under the guidance of the Clinical Research Coordinator and Manager, assisting with research study documentation and IRB submissions, and entering research data into the electronic data capture system (EDC). The role also involves assisting with the calibration and certification of equipment and rooms as required by study sponsors and maintaining patient Electronic Health Records and regulatory binders. Training in ophthalmic techniques as required by the team is also part of the responsibilities. Additional duties include analyzing and coordinating subspecialties, reviewing physicians' schedules, handling referrals, and obtaining medical records. This position will also support the creation and maintenance of patient records, schedule visits, and provide training to new hires. Other tasks may be assigned as needed to support the CRU and clinic.

Why UT Southwestern?

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As one of the world's foremost research institutions, UT Southwestern Medical Center is known for our life-changing research that has led us to 6 Nobel Prizes. As a Clinical Research Assistant I, this position will involve the meticulous collection and entry of crucial data, contributing to the ongoing research initiatives. This position will also conduct preliminary analysis to support research objectives. Additionally, this position will assist Dr. Karanjit Kooner with day-to-day correspondences, ensuring seamless communication within the team. With a commitment to being 100% on campus, this will contribute to the collaborative and dynamic environment of Dr. Kooner's research endeavors. Experience in ophthalmology is preferred.

Experience and Education

Minimum Requirements

• High School diploma or GED with no experience.
• A minimum of Heart Saver for non-licensure or BLS for Licensure may be required based on research study protocols or affiliate location requirements.
• High Preferred to be Bi-Lingual in English and Spanish

Job Duties

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

• 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.
• Understands visit schedules, inclusion/exclusion criteria and protocol requirements for routine and low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits.
• Assists research staff by completing research protocol related tasks.
• Assists with preparing annual reports and/or modifications to institutional review board (IRB).
• This may include reportable events (UPIRSO).
• Reviews and abstracts information from medical records including eligibility criteria.
• Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.
• Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order.
• With adequate training and supervision, assists with collecting and processing specimens following established procedures/protocols.
• Assists in preparing studies for closeout, (e.g. packing files, documenting files for storage, shipping extra supplies back to sponsor).
• 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.
• 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

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

Working Conditions

Work is performed primarily in an office environment but may require periodic visits to clinical and off-site clinical areas for purpose of interviewing patients. May require local or out-of-state travel based on research study.

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.