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Title:  Senior Clinical Research Associate

Division:  Pediatrics
Schedule:  Monday - Friday, 8 AM to 5 PM
Work Location:  Texas Medical Center, Houston, TX
Salary Range:  $56,895 - $80,317
FLSA Status:  Exempt
Requisition ID:  9708

Summary

Supports daily operations for research studies or clinical trials in Pediatric Cardiology, under the minimal guidance from the Principal Investigators (PI's) and supervisor. Serves as a resource regarding clinical research rules and regulations for faculty and staff and independently manages projects from initiation to closeout.

 

This position is primarily responsible for patient care in a Pediatric Cardiology clinical research area. Duties may include consenting, screening and enrolling subjects, obtaining blood and other specimens for tests, administering medications, recording data for research analysis, maintaining patient records, preparing electronic data entry in the different databases (departmental, institutional, and external), and writing and maintaining Institutional Review Board (IRB) protocols for assigned projects. In addition, may be assigned to oversee research data collection, entry, and analysis.

Job Duties

•    Be the lead on assigned projects from initiation to closeout with background and experience to independently oversee and manage sponsored drug, device and/or investigator initiated clinical trials in Pediatric-Cardiology, with minimal guidance.
•    Provides training and mentors work of less experienced staff on the team.
•    Recruits, screens, enrolls, consents, and schedules study participants. 
•    Collects and processes samples from participants.
•    Independently oversees and coordinates the collection, entry, and analysis of research data; may develop and maintain databases or participant charts.
•    Writes and edits Standard Operating Procedures (SOP's) for clinical research activities in Pediatric-Cardiology.
•    Collects and reports adverse events.
•    Serves as a liaison and distributes research information to faculty, research staff, principle investigator, and others as required.
•    Works with Principal Investigator on both local and commercial Institutional Review Board (IRB) protocols, including but not limited to new protocol submission, amendments and renewals.
•    Provides training and guidance to research personnel in Pediatric Cardiology and serves as a resource to faculty and staff.
•    Follow subjects' progress and advises the Principal Investigator.
•    Documents clinical research data in electronic data capture (EDC) in accordance with protocol requirements. 
•    Oversees site monitoring visits in collaboration with the study sponsor and institutional offices, and manage all study related documents with the study sponsors, and internal and external stakeholders for the multiple projects assigned.
•    May perform Venipuncture (blood draws), EKGs/ECG's and obtain vital signs on study participants - on the job training would be provided for these activities.
•    Validates research data entered in the study database/ registry. Works and manages project databases (REDCap, etc.), troubleshoots and creates new surveys for data collection.
•    Orders supplies and equipment.
•    May maintain research data in databases/registry; conduct periodic review of data for accuracy.
•    Participates in clinical and research meetings as required.

Minimum Qualifications

  • Bachelor's degree.
  • Four years of relevant experience.

Preferred Qualifications

•    Good knowledge of GCP, FDA and other applicable regulations governing the conduct of clinical trials.
•    Independent critical thinking and troubleshooting regarding assigned projects.
•    The ideal candidate will be self-motivated and capable of working both independently and as a member of the project team. 
•    Must have excellent time management and organization skills.
•    Clinical research project management experience.
•    SOCRA Clinical Research Professional or similar certification.

 

 

Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

 

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

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