Clinical Research Assistant II, Simmons Cancer Center - Richardson

University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

PPO medical plan

Paid Time Off

Retirement Programs through TRS

Paid Parental Leave

Tuition Reimbursement

PSLF Qualified Employer

Wellness programs

Job summary

UT Southwestern Medical Center in Dallas, TX seeks a Clinical Research Assistant II to support data management for local and national studies. The role may involve coordinating observational trials, consenting participants, and assisting with study documentation under PI guidance.

Based at Richardson, the position may travel to regional clinics for coverage needs, contributing to monitor visits, data submission, and coordination of trial activities through the continuum of care.

Qualifications

• Knowledge of applicable Federal and institutional regulations governing clinical research.
• 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).
• Possess strong computer skills (spreadsheets, databases, and interactive web-based software).
• Possess good communication skills.

Responsibilities

• Interact with investigators, staff and participants to coordinate trial activities.
• Enter and verify data in case report forms and data systems.
• Schedule visits and monitor study progress and audits.
• Ensure data quality and regulatory compliance for regulatory submissions.
• Assist with preparing reports and IRB submissions and audits.
• Support recruitment and enrollment of participants when needed.

Skills

Organizational skills

Computer skills

Communication skills

PHI regulations

Problem solving

Education

High School Diploma

Associate's Degree

Bachelor's Degree

Job description

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 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 No. 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 youll discover a culture of teamwork, professionalism, and a rewarding career!

JOB SUMMARY

Works under the direction of an Investigator(s) with general supervision, to provide ongoing data management for local and national research studies and may coordinate observational (non-treatment/treatment) trials/studies. May provide supporting role for more complex studies under the direction of the PI, Clinical Research Coordinator and/or Clinical Research Lead.

This position will be based at Richardson full-time. Additionally, the clinical research assistant II maybe asked to travel to other regional clinics in times of coverage needs. The clinical research assistant II will schedule, prepare for, and manage all monitoring visits and audits for the sites. This role interfaces with physicians and patients seeking to participate in treatment trials for their cancer. The clinical research assistant II will be responsible for data submission, research blood sample processing review, performing EKGs on patients, eligibility for prospective patients, schedule procedures in accordance with the IRB approved protocol, participates in the screen process, consent process, and coordinates trial activities through their continuum of care. They will participate in tumor boards, monthly disease-oriented team meetings, and other conferences with physicians and team member.

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 medical or science related field and no prior experience
• Experience
  2 years experience with High School Diploma or
  1 year experience with Associate's Degree

Preferred

• Licenses and Certifications
  (BLS) BASIC LIFE SUPPORT may be required based on affiliate location requirements.
  (CPRAED) CPR AED may be required based on affiliate location requirements.

JOB DUTIES

• Understands visit schedules, criteria and protocol requirements for low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits.
• Assists research staff by completing research protocol related tasks.
• Reviews and abstracts information from medical records including eligibility criteria.
• 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.
• 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.
• Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.
• With adequate training and supervision, assists with participant screening and recruitment for more complex trials.
• Conducts and documents consent for participants in studies. Assists with the development of consent plans and documents for participants.
• Identifies incomplete, inaccurate, or missing data for more complex studies and works with lead coordinator to correct errors.
• 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.
• 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.
• Performs other duties as assigned.

Knowledge, Skills and Abilities

• Knowledge of applicable Federal and institutional regulations governing clinical research.
• 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.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS

Working Conditions

• Clinical Setting
• Office Setting

Salary Information

Salary is commensurate with education, skills, and relevant experience.

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.