Research Coordinator I
Baylor College of Medicine
Job posting number: #7135925 (Ref:15182-en_US)
Posted: March 24, 2023
Application Deadline: Open Until Filled
The Department of Medicine, Section of Gastroenterology and Hepatology, is looking for a experienced Research Coordinator to coordinate day to day activities of clinical trials activities. The candidate will work with a team and alongside Dr. Mohamed Othman. Duties and responsibilities include working directly with research patients on screening, enrolling, and monitoring for clinical trial compliance. The candidate will manage and enter data into study databases. Duties will also include regulatory reporting and compliance, as well as writing IRB protocols, including amendments and renewals. Duties will also include involvement in observational trials. The position is full-time, 5 days a week.
- Recruits and interviews potential study participants in non-therapeutic and therapeutic studies.
- Collects patient information; processes documents and enters information into a database.
- Collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol.
- Plan and schedule upcoming research visits for study subjects, according to protocol requirements.
- Maintains appropriate documentation. Tracks 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.
- Liaises with PI, Sponsor, Research Manager and OCR Research Finance to support all aspects of study activity
- 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.
- Coordinate Site Monitoring visits with sponsor,CRO, study team, investigational pharmacy, and Principal Investigator.
- Facilitate the study start up process, including: Draft multiple study documents to initiate the study start up process at the site.
- Assist with data collection and reporting of Serious Adverse Events to appropriate regulatory agencies and sponsors.
- Coordinate IRB applications to local/central IRB.
- Order supplies and equipment.
- High School diploma or GED.
- Three years of relevant experience.
- Bachelor's degree in a related field.
- Clinical trial drug experience
- Must be experienced with Excel spreadsheets and research database use
- Must have the ability to understand and implement patient studies and protocols
- Experience with research publications
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.