Clinical Research Assistant I, Internal Medicine Cardiology

UT Southwestern Medical Center • Dallas, TX

17h

About The Position

Works under the direction of an Investigator(s) with general supervision, to primarily provide ongoing data management for local and national research studies. May coordinate observational (non-treatment) studies.
Additional responsibilities:
Coordinates assigned human subjects research studies or defined components of larger clinical research projects through direct interaction with and providing care for patients or research participants.
Leads day-to-day study operations, such as participant recruitment, informed consent processes, study visits, and protocol execution. This may include preparing and reviewing medical records, contacting patients by phone, conducting participant surveys, organizing logistics related to participant visits, entering and reviewing clinical data, and handling administrative tasks.
Prepares, maintains, and organizes regulatory documents including IRB submissions, amendments, renewals, and study binders.
Regularly maintaining, modifying, releasing or similarly affecting patient and research participant records.
Ensures accurate, timely, and complete data collection and performs routine quality control and data reconciliation activities.
Assists with biospecimen handling, processing, tracking, and shipment according to protocol and institutional guidelines, when applicable.
Purchases office equipment, software, and laboratory supplies, maintaining inventory and expense records.
Serves as a primary point of contact for assigned research projects.
Assists with preparation of study reports, grant progress updates, abstracts, manuscripts, and other documents by organizing data and documentation.
Provides functional guidance or training to new team members as assigned.
Participates in quality assurance activities by preparing relevant data and documentation.

Requirements

• High School Diploma or GED
• (BLS) BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements.
• (CPRAED) CPR AED may be required based on affiliate location requirements
• 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, 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.
• 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.

Nice To Haves

• Demonstrated experience coordinating clinical or human subjects research studies.
• Experience with IRB processes, regulatory documentation, and protocol implementation.
• Experience creating, managing and using REDCap
• Familiarity with Good Clinical Practice (GCP) and clinical trial workflows.
• Ability to manage multiple projects, meet deadlines, and work independently within a research team.
• Experience with phlebotomy and biospecimen handling and processing, including phlebotomy technician certification, experience handling and maintaining relevant equipment and preparing plasma, serum, whole blood, peripheral blood mononuclear cells and urine for long-term storage in -80C and liquid nitrogen.
• Interest in pursuing a career in clinical research, medicine, public health, or related health professions.
• Bilingual (English and Spanish)

Responsibilities

• Ongoing data management for local and national research studies
• Coordinate observational (non-treatment) studies
• Coordinates assigned human subjects research studies or defined components of larger clinical research projects through direct interaction with and providing care for patients or research participants.
• Leads day-to-day study operations, such as participant recruitment, informed consent processes, study visits, and protocol execution.
• Prepares, maintains, and organizes regulatory documents including IRB submissions, amendments, renewals, and study binders.
• Regularly maintaining, modifying, releasing or similarly affecting patient and research participant records.
• Ensures accurate, timely, and complete data collection and performs routine quality control and data reconciliation activities.
• Assists with biospecimen handling, processing, tracking, and shipment according to protocol and institutional guidelines, when applicable.
• Purchases office equipment, software, and laboratory supplies, maintaining inventory and expense records.
• Serves as a primary point of contact for assigned research projects.
• Assists with preparation of study reports, grant progress updates, abstracts, manuscripts, and other documents by organizing data and documentation.
• Provides functional guidance or training to new team members as assigned.
• Participates in quality assurance activities by preparing relevant data and documentation.
• 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, 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.
• 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.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100%25 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees