Plans, organizes, and conducts research in assigned clinical department for use in own work or in projects of the institution by performing the following duties. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles. The employee is occasionally exposed to toxic or caustic chemicals. The noise level in the work environment is usually moderate.
Serves as Clinical Research Coordinator/Assistant on multiple protocols, with multiple PIs depending on complexity study and condition of study patient population not to exceed the number determined safe to conduct as directed by supervisor. Research specific to Pulmonary, Cardiac, and ICU which may involve both in-patient (ICU) and out-patient research. Coordinates daily operations of clinical (human) research studies in Internal Medicine, Pulmonary Critical Care Division, with a major focus on pulmonary related diseases
Prepares/submits IRB required documents, including but not limited to, Initial Review, Study Protocol, Informed Consent Forms, Questionnaires, Study Recruitment/advertising material, Investigator Brochure, IND safety reporting, Continuing Reviews, Adverse Events (AE) and Serious Adverse Events (SAE)and other IRB documentation
Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places on Informed Consent Form (ICF) & HIPAA form. Assures that amended consent forms are appropriately implemented and signed
Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials. Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.)
Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document/form, case report forms (CRFs), enrollment/screening logs, and drug/device accountability logs
Reviews and comprehends the research protocol. Screen potential study patients – evaluate protocol defined inclusion and exclusion criteria. Explain research and medical procedures to study patients (and family if needed) in Spanish if necessary. Answer patient questions, re-iterated MD instructions and interpret if necessary
Schedule research related patient visits. Assists physician with scheduling of necessary procedures and escorts subjects to procedures in the hospital. Schedules, prepares for, and staffs routine visits from CRAs monitoring research procedures
Collects data as required by the protocol. Records research data. Collects necessary information from patient charts (i.e., medications, laboratory, ECG and x-ray reports, and charge sheets) and records data in source documentation
Process routine clinical samples (i.e. blood, urine) and label specimens appropriately and assure prompt shipping if to outside laboratory. Submit request for dry ice and ship and label samples. Process routine clinical samples (i.e. blood, urine) and label specimens appropriately and assure prompt shipping if to outside laboratory. Submit request for dry ice and ship and label samples
Performs needed procedures for protocol defined research/clinic visits. Takes vital signs, weight, height measurements and records in patient’s chart (or source doc) and in summary reports and documents. Perform routine clinical tests including but not limited to, draw blood samples, take blood pressure, perform ECGs, etc.
Communicate medical findings with PI – with PI advise documentation of AE, SAE and IRB/Sponsor reporting
Maintains adequate inventory of study supplies. Maintains supplies needed for multiple research studies. Maintains study drug supply for PI (when applicable)
Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study. Reply to sponsor request for data clarification (aka queries, DCF, etc)
Periodically attend Investigator Meetings required by pharmaceutical study sponsors outside El Paso
Associate’s degree in a field of study related to the clinical research trial plus one (1) year related experience or a combination of related education and/or experience to equal three (3) years
Certified Clinical Research Professional as defined by The Society of Clinical Research Associates or ability to obtain certification as a Clinical Research Professional within two years from date of hire or upon eligibility
Bilingual – Spanish/English
Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors
Knowledge of medical terminology
Excellent organizational skills to independently manage workflow
Ability to prioritize quickly and appropriately
Ability to multi-task
Meticulous attention to detail
Familiarity with Microsoft Office Suite
The ideal candidate would have experience in:
Pulmonary and/or critical care or work as a respiratory therapist, clinical research/human subjects research experience involving research of medications in the process of being approved by the FDA by pharmaceutical companies (not animal, basic, or epidemiologic research)
Previous work with CRFs and EDC
Knowledge of good clinical practice, FDA , OHRP, HIPPA, policies. IATA training in shipping biologic specimens
As an EEO/AA employer, the Texas Tech University System and its components will not discriminate in our employment practices based on an applicant’s race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information or status as a protected veteran.
Does this position work in a research laboratory?
Are select agents used in this laboratory?
Minimum Hire Rate
Compensation is commensurate upon the qualifications of the individual selected and budgetary guidelines of the hiring department, as well as, the institutional pay plan. For additional information, please reference the institutional pay plan on the Human Resources webpage.
Up to 25%