Clinical Research Assistant II, Simmons Cancer Center - Richardson

UT Southwestern Medical Center•Dallas, TX

5d•Onsite

About The Position

Works under the direction of one or more investigators with general supervision to provide ongoing data management for local and national research studies and may coordinate observational or treatment trials and studies. The role may support more complex studies under the direction of the principal investigator, clinical research coordinator, and/or clinical research lead. This full-time position is based in Richardson, with possible travel to other regional clinics when coverage is needed. The assistant schedules, prepares for, and manages site monitoring visits and audits, and interfaces with physicians and patients interested in cancer treatment trials. Responsibilities include submitting data, reviewing research blood sample processing, performing EKGs, assessing prospective patient eligibility, scheduling protocol-compliant procedures, participating in screening and consent processes, and coordinating trial activities throughout participants’ care. The role also participates in tumor boards, monthly disease-oriented team meetings, and other conferences with physicians and team members.

Requirements

High school diploma and two years of experience; or an associate’s degree in a medical- or science-related field and one year of experience; or a bachelor’s degree in a medical- or science-related field with no prior experience.
Knowledge of applicable federal and institutional regulations governing clinical research.
Knowledge of clinical research protocols.
Effective organizational skills and attention to detail.
Ability to proactively maximize results for the team and organization.
Knowledge of and ability to follow regulations governing protected health information (PHI).
Strong computer skills, including spreadsheets, databases, and interactive web-based software.
Good communication skills.
Ability to problem solve.
Ability to conduct interviews with research subjects.

Nice To Haves

Basic Life Support (BLS) certification may be required based on affiliate location requirements.
CPR/AED certification may be required based on affiliate location requirements.

Responsibilities

Understand visit schedules, criteria, and protocol requirements for low-complexity trials and schedule research visits.
Assist research staff with research protocol-related tasks.
Review and abstract medical-record information, including eligibility criteria.
Enter data into case report forms or other study data collection systems and help maintain study documentation.
Assist with data queries and edits to ensure accuracy.
Compile data for regulatory requirements and local or sponsor submission deadlines.
Maintain existing databases and ensure data integrity.
Perform clinical analysis and data checks for quality assurance and quality control using trial-related databases.
Assist with annual reports and institutional review board (IRB) modifications, including reportable events as applicable.
Prepare research records for sponsor or internal audits.
Recruit and enroll study participants; after training and with supervision, conduct consent and support screening and recruitment for more complex trials.
Conduct and document participant consent, and assist with developing consent plans and documents.
Identify incomplete, inaccurate, or missing data for more complex studies and work with the lead coordinator to correct errors.
Order and maintain research supplies according to university and department procedures, and help ensure equipment is in good working order.
With adequate training and supervision, collect and process specimens according to established procedures and protocols.
Assist with study closeout, including packing and documenting files for storage and returning extra supplies to sponsors.
With adequate training, credentialing, and supervision, perform study procedures such as phlebotomy, vital signs, and EKGs; other procedures, equipment, or services may be required depending on the study.
May perform basic patient care under the PI’s direction and according to the scope of work document.
Perform other duties as assigned.
Schedule, prepare for, and manage site monitoring visits and audits.
Submit research data, review research blood sample processing, perform EKGs, assess prospective patient eligibility, schedule protocol-compliant procedures, and coordinate trial activities throughout the continuum of care.
Participate in tumor boards, monthly disease-oriented team meetings, and other conferences with physicians and team members.
May travel to other regional clinics when coverage is needed.

Benefits

PPO medical plan available on day one at no cost for full-time employee-only coverage.
Preventive healthcare coverage at 100% with no copay.
Paid time off available on 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.
Competitive benefits package includes healthcare and paid holidays.
On-site childcare.
Wage and merit increases.