Research Coordinator III
Baylor College of Medicine
Job posting number: #7122122 (Ref:14533-en_US)
Posted: January 26, 2023
Application Deadline: Open Until Filled
Experienced clinical research coordinator to be an active team member in a research center specializing in infectious diseases treatments, prophylaxis, and epidemiologic research.
- Understands assigned research trials with complete familiarity of the protocol, manual of procedures, FDA regulations, Good Clinical Practice guidelines, standard operating procedures, and other established guidelines.
- Recruits, screens, enrolls, and evaluates study participants for focused research trials.
- Educates study participants to the objectives and requirements for IRB-approved research protocols.
- Coordinates clinic schedules including participant visit appointments, laboratory, and pharmacy involvement.
- Explains study processes and procedures to study participants including informed consent and eligibility requirements, which are of utmost importance.
- Tracks compliance of participants with study requirements and implements resolution measures when non-compliance is observed.
- Conducts all study visits according to protocol requirements.
- Collects, documents, and reconciles data according to protocol, manual of procedures, Sponsor, and federal requirements and guidelines.
- Assesses safety parameters by collecting adverse event and serious adverse event data, determines the significance of each event, and engages the physician investigator when necessary and appropriate.
- Is primary contact for assigned research trials for Sponsors, Sponsor agents, research team members, data coordinating center, federal agencies, and study participants. • Prepared to answer questions, organize personnel, coordinate schedules, and manage data queries related to the research trial.
- Maintains research records in a secure and confidential manner.
- Participates in quality management reviews and determines appropriate resolution of findings including initiating a corrective action plan when needed.
- Collects vital signs, blood and other biological samples according to established procedures.
- Enters data into study-specific database systems and conducts quality control reviews to ensure accuracy.
- Collaborates with regulatory, laboratory, pharmacy, and quality management personnel to ensure that processes and procedures are compliant with established guidelines and to rectify discrepancies, as needed.
- Facilitates monitoring visits by collaborating with Clinical Research Associates and by responding to queries when needed.
- Obtains and reviews clinical laboratory results and submits the results to a physician investigator. Repeats abnormal laboratory tests, as needed, until test results return to normal (or as required in the protocol).
- Inventories, orders, and stocks clinic supplies and equipment when needed.
- Calibrates clinic equipment as assigned.
- Administers study products according to protocol guidelines.
- Maintains a clean and safe work environment.
- Performs other job-related duties as assigned.
- Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
- Two years of relevant experience.
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.
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.