Job Description

Extended Job Title
Clinical Research Coordinator (Internal Medicine)

Org Level 1
Texas Tech Unv Hlth Sci Ctr El Paso

Position Description
Coordinates daily operations of clinical research studies in assigned department(s). This includes but is not limited to overall clinic conduct, marketing, and data management of all clinical research activities in assigned department(s). Carries out supervisory responsibilities in accordance with policies and applicable laws. Responsibilities may include training new employees; assisting with planning, assigning, and directing work; addressing complaints and resolving problems. The employee is frequently exposed to fumes or airborne particles. The employee is occasionally exposed to toxic or caustic chemicals and dangerous bodily fluids. The noise level in the work environment is usually moderate. Approximately 5-15% travel (often long-distance) is required.

Requisition ID
32845BR

Optional Attachments
Professional License/Certification, Transcript

Travel Required
Up to 25%

Major/Essential Functions
  • Responsible for coordinating patient enrollment into clinical research studies, confirming eligibility criteria, providing patient education, and obtaining informed consent. Research specific to GI (gastroenterology). Coordinates daily operations of clinical (human) research studies in Internal Medicine, GI Division, with a major focus on digestive related diseases and conditions.
  • 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 , 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). 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. Coordinate and schedule patients' study visits, and required clinical testing as well as any required imaging, scans, or procedures required by research protocol. 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.
  • 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.


Grant Funded?
No

Minimum Hire Rate
Compensation is commensurate upon the qualification

Pay Basis
Monthly

Work Location
El Paso

Preferred Qualifications
  • Bilingual: Spanish/English
  • Preferred 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)
  • Preferred experience with GI (digestive) medical conditions and diseases
  • Previous work with clinical (pharmaceutical) research trials and with CRFs and EDC
  • Knowledge of good clinical practice, FDA, OHRP, HIPAA policies.6) IATA training in shipping biologic specimens a plus
  • Experience with conducting grant funded, investigator initiated research (NIH, CPRIT, AGA, etc)
  • Experience performing routine clinical tests such as taking vital signs, blood pressure, performing ECGs, and drawing blood highly desired


Campus
HSC - El Paso

Department
Internal Medicine Elp Genl

Required Attachments
Cover Letter, Resume / CV

Job Type
Full Time

Pay Statement
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 by visiting the Human Resources website.

Job Group
Clinical Research Professional

Shift
Day

EEO Statement
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.

Required Qualifications
  • Healthcare related training with current licensure/certification in their field OR Bachelor's degree from an accredited university with a major in the area of research being conducted
  • Certified Clinical Research Professional as defined by The Society of Clinical Research Associates or Certified Clinical Research Coordinator as defined by the Association of Clinical Research Professionals OR ability to obtain certification as a Clinical Research Professional/Coordinator within two years from date of hire or upon eligibility


Does this position work in a research laboratory?
Yes

Are select agents used in this laboratory?
Yes

Navy Enlisted Classification Code
230X

Air Force Specialty Code
43BX

Jeanne Clery Act
The Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act is a federal statute requiring colleges and universities participating in federal financial aid programs to maintain and disclose campus crime statistics and security information. By October 1 of each year, institutions must publish and distribute their Annual Campus Security Policy & Crime Statistics Report (ASR) to current and prospective students and employees. You can locate this report through our website at: https://www.ttuhsc.edu/emergency/clery-report.aspx

Application Instructions

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