Clinical Research Assistant II

UT Southwestern Medical Center • Dallas, TX

4d

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. Responsibilities include collecting, processing, and shipping clinical-trial blood samples, including drawing blood from adult and pediatric study patients; maintaining consent files and IRB documentation; and entering participant data into databases. The assistant also supports IRB record keeping, informed consent, and responses to study inquiries and sponsor audit-information requests on behalf of the Principal Investigator. Phlebotomy certification is required within six months of hire. A personal car is required to collect blood from offsite patients when needed; mileage reimbursement is provided.

The position performs research coordination and data tasks for studies of varying complexity, including scheduling visits, reviewing medical records, completing case report forms, maintaining databases and study documentation, and supporting regulatory submissions and audits. With appropriate training, credentialing, and supervision, the assistant may recruit and enroll participants, obtain consent, collect and process specimens, and perform study procedures such as phlebotomy, vital signs, and EKGs. Work takes place in clinical and office settings. Salary is commensurate with education, skills, and relevant experience.

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.
• Phlebotomy certification required within six months of hire.
• Must have a personal car to collect blood from offsite patients when needed.
• Knowledge of applicable federal and institutional regulations governing clinical research.
• Knowledge of clinical research protocols.
• Effective organizational skills and attention to detail.
• Ability to work proactively to maximize team and organizational results.
• Knowledge of and ability to follow regulations for 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 depending on affiliate-location requirements.
• CPR/AED certification may be required depending on affiliate-location requirements.

Responsibilities

• Understand visit schedules, eligibility criteria, and protocol requirements for low-complexity trials, and schedule research visits.
• Complete research protocol-related tasks to assist research staff.
• Review and abstract medical-record information, including eligibility criteria.
• Enter study data into case report forms or other data-collection systems and assist with maintaining 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 quality assurance and quality control clinical analysis and data checks using study databases.
• Assist with annual reports and modifications to the institutional review board (IRB), including reportable events.
• Prepare research records for sponsor or internal audits.
• Recruit and enroll study patients; after training and with supervision, obtain participant consent.
• Assist with screening and recruitment for more complex trials with adequate training and supervision.
• 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.
• Assist with ordering and maintaining research supplies and ensure equipment is in good working order.
• With adequate training and supervision, collect and process specimens according to established procedures and protocols.
• Assist in 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 or equipment may be required depending on the study.
• May perform basic patient-care skills under the direction of the Principal Investigator and within the scope of work.
• Collect, process, and ship research clinical-trial blood samples, including drawing blood from adult and pediatric study patients.
• Maintain study-subject consent files and IRB records, and enter subject data into databases.
• Assist the Principal Investigator with IRB record keeping and obtaining informed consent from subject families; respond to study inquiries and sponsor audit-information requests on the Principal Investigator's behalf.
• Perform other duties as assigned.

Benefits

• PPO medical plan, available on day one at no cost for full-time employee-only coverage.
• 100% coverage for preventive healthcare 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.
• Mileage reimbursement for collecting blood from offsite patients.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED