The Cardiac Electrophysiology Section at Baylor College of Medicine delivers cutting-edge research focused on cardiac arrhythmias. This role is a unique opportunity to provide centralized coordinator support within the Cardiac Electrophysiology Section to multiple PIs on both therapeutic drug and device clinical research trials. This position is essential for coordination of EP research portfolio at BCM and Baylor St. Luke’s Medical Center (BSLMC), liaising with principal investigators (PIs), regulatory staff, sponsor representatives, investigational pharmacy, and clinical team members to ensure that research studies are performed per federal regulations, sponsors' guidelines, and departmental policies. The Senior Clinical Research Coordinator role provides coordinator support to fast-paced and detailed therapeutic drug and device clinical research trials at BSLMC and BCM, across a variety of arrhythmias. This position requires ability to coordinate multiple research studies with multiple PIs. Ability to coordinate study activities that can be scattered across campus, and not always in the same location.
Under direction of PI, drafts various communications with the Sponsor and/or regulatory documents to be sent to the Sponsor.
Trains clinical research personnel regarding enrollment/recruitment protocols and processes, identifying and clinical research subjects; monitoring enrollment goals and modifying recruitment strategies, as necessary.
Precepts new clinical research staff and educating staff regarding scientific aspects of studies. Serving as a resource for the clinical research staff.
Collaborates with research team by actively communicating and reporting pertinent information as it relates to assigned system(s) in a comprehensive manner.
Teaches peers to critically think by verbally expressing rationale for decisions and follows up consistently. Uses peer-to-peer accountability towards improvement of department score for turnover/retention/employee engagement.
Serves as disease area team lead, assisting with study startup processes and feasibility for verification of staffing resources, patient population, clinical resources, etc.
Participates in the PI meetings and in-service nurses and physicians.
Leads, organizes and participates in pre-site and site initiation visits.
Completes initial patient assessments, per competence, utilizing interview, observation and examination; obtaining vital signs and performs phlebotomy; performs phlebotomy per training and competence.
Assists in budget development and CMS coverage analysis and study billing management.
Independently manages time and prioritizes tasks.
Provides ongoing communications with study subjects.
Prepares IRB documents under the direction of the PI, assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.
May coordinate travel requests and reimbursements.
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.
Therapeutic clinical research study experience.
ACRP Certified Clinical Research Coordinator or SOCRA Certified Clinical Research Professional certification.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care.
- Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective.
- Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve.
- Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.