What are the responsibilities and job description for the Lead Clinical Research Assistant, Otolaryngology position at UT Southwestern?
Lead Clinical Research Assistant - Otolaryngology Department
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!
JOB SUMMARY
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 Research Manager and the PI.
BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
PPO medical plan, available day one at no cost for full-time employee-only coverage
100% 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
Learn more about these and other UTSW employee benefits!
EXPERIENCE AND EDUCATION
Required
Education
High School Diploma or
Associate's Degree in medical or science related field or
Bachelor's Degree or higher in medical or science related field
Experience
4 years of experience with High School Diploma or
2 years of experience with Associate's Degree or
1 year of experience with Bachelor's Degree or higher
Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience.
Preferred
Licenses and Certifications
(BLS) BASIC LIFE SUPPORT may be required based on research study protocol or affiliate location requirements.
(CPRAED) CPR AED may be required based on research study protocol or affiliate location requirements.
JOB DUTIES
Assists 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, 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.
Performs other duties as assigned.
SECURITY AND EEO STATEMENT
Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
EEO
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.
- This position will be based at Children's Hospital*
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!
JOB SUMMARY
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 Research Manager and the PI.
BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
PPO medical plan, available day one at no cost for full-time employee-only coverage
100% 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
Learn more about these and other UTSW employee benefits!
EXPERIENCE AND EDUCATION
Required
Education
High School Diploma or
Associate's Degree in medical or science related field or
Bachelor's Degree or higher in medical or science related field
Experience
4 years of experience with High School Diploma or
2 years of experience with Associate's Degree or
1 year of experience with Bachelor's Degree or higher
Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience.
Preferred
Licenses and Certifications
(BLS) BASIC LIFE SUPPORT may be required based on research study protocol or affiliate location requirements.
(CPRAED) CPR AED may be required based on research study protocol or affiliate location requirements.
JOB DUTIES
Assists 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, 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.
Performs other duties as assigned.
SECURITY AND EEO STATEMENT
Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
EEO
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.