Division: Breast Center

Work Arrangement: Onsite only

Location: Houston, TX

Salary Range: $67,704 - $78,514

FLSA Status: Exempt

Work Schedule:: Monday - Friday, 8 a.m. - 5 p.m.

Summary

At the Lester and Sue Smith Breast Center at Baylor College of Medicine we study almost every aspect of breast health and disease and are focused entirely on strategies to prevent, diagnose and treat all breast cancer. We are a multidisciplinary center with an emphasis on translational research. Seeking an experienced Senior Research Coordinator who will be responsible for multiple clinical projects in Breast Cancer research under the direction of the principle investigator and clinical research manager. This position will support the PI to facilitate clinical trial accrual and study activities, working with BCM staff across multiple clinic locations and teams in the Dan L Duncan Cancer Center.

Job Duties

• Manage and coordinate the special collection tissue biobanking program for the Breast Oncology Center.
• Explain process and procedures to educate participants regarding the research study in English and Spanish.
• Create applicable source forms/translate documents for each study assigned in English and Spanish.
• Create, update, and edit applicable SOP forms for each study protocol assigned.
• Gather, maintain, clean, and submit all necessary participant data acquired in their respective EDC/database.
• Maintain communication with all sponsors and PI in accordance with each protocol.
• Ensure timely submissions of all ICFs and other relevant forms to the IRB.
• Perform data abstraction as specified by each assigned study.
• Perform data analysis including retrieving data, cleaning raw data, and analyzing data that is pertinent to our current study protocol.
• Train new incoming employees in study protocols and clinical research principles and techniques.
• Report all AEs/SAEs in a timely manner in accordance with each protocol to the PI, sponsor, and IRB when necessary.
• Attend and support study audits, both internal and external.
• Collect, process, ship, and maintain blood and/or biological specimens according to procedures outlined in study protocol.
• Maintain records and regulatory documents and records for research studies.
• Schedules research participant for tests and procedures, and other studies specific for the research protocol.
• Retrieve and submit test results to appropriate party.
• Maintain patient follow up through correspondence with each participant as outlined in the study protocol.
• Recruit & interview potential study participants at multiple sites at Baylor Clinic, St. Luke's and Harris Health and tracks approaches using electronic medical records (EPIC) and bio-bank database.
• Collect patient information; processes documents and enters information into a database.
• May collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol. May perform venipuncture (blood draws) on study participants following adequate training and certification.
• Maintain records and regulatory documents and records for research studies.
• Maintain appropriate documentation. Track IP compliance at the protocol-and subject level. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
• Patient education for patients with varying levels of health literacy, obtaining consent, and explaining all aspects of consent form and consent procedures to patients of varying cultural and educational backgrounds.
• Schedules research participant for tests and procedures such as laboratory tests, imaging, and other studies specific for the research protocol. Retrieves and submits test results to appropriate party.
• Attends regular meetings with Research Manager, PIs, and study team for update reports and process improvement.
• Provides cross-coverage on study activities across research team as needed.
• Other duties as assigned.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.
• Clinical trial drug and/ device experience preferred.
• Oncology research study experience preferred.
• ACRP Certified Clinical Research Coordinator or SOCRA Certified Clinical Research Professional certification preferred.
• Bilingual--Spanish proficiency preferred.
• Must be willing to work in a fast-paced and dynamic work environment.
• Should be self-motivated and able to balance a complex work schedule (early mornings/late afternoons).

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

Requisition ID: 19690