Baylor College of Medicine
Research Coordinator I - Medicine
Baylor College of Medicine, Houston, Texas, United States, 77246
Division: Medicine
Work Arrangement: Onsite only
Location: Houston, TX
Salary Range: $39,150 - $46,059
FLSA Status: Nonexempt
Work Schedule: Monday - Friday, 7:30 a.m. - 4:30 p.m.
Summary
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. 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 as well as additional tasks that may be assigned by the PI. The position is full-time, 5 days a week.
Job Duties
Recruits and interviews potential study participants in non-therapeutic and therapeutic studies.Collects patient information; processes document 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 activitySchedules 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.Orders supplies and equipment as needed by study team.Participates in weekly scheduled research team meetings to provide study updates and progress.Performs other job duties as assigned.Other
May be asked to collaborate on writing scientific abstract and manuscripts (if able).Will also gain experience working as a scribe in the Gastroenterology clinic one day weekly per PI schedule.Occasionally may be given research interns (typically high school or undergraduate) to assist with tasks depending on their availability.Minimum Qualifications
High School diploma or GED.Three years of relevant experience.Preferred Qualifications
Bachelor's degree in a related field. No experience required with preferred degree.Industry sponsored Clinical Trial ExperienceMust be experienced with Excel spreadsheets and research database use such as REDCap/OnCore/EDCs.Must have the ability to understand and implement patient studies and protocols.Ability to speak Spanish is a plus but not mandatory.Organized, self-motivated, can teamwork, works well under pressure, engages in multitasking.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Requisition ID: 21053
Work Arrangement: Onsite only
Location: Houston, TX
Salary Range: $39,150 - $46,059
FLSA Status: Nonexempt
Work Schedule: Monday - Friday, 7:30 a.m. - 4:30 p.m.
Summary
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. 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 as well as additional tasks that may be assigned by the PI. The position is full-time, 5 days a week.
Job Duties
Recruits and interviews potential study participants in non-therapeutic and therapeutic studies.Collects patient information; processes document 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 activitySchedules 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.Orders supplies and equipment as needed by study team.Participates in weekly scheduled research team meetings to provide study updates and progress.Performs other job duties as assigned.Other
May be asked to collaborate on writing scientific abstract and manuscripts (if able).Will also gain experience working as a scribe in the Gastroenterology clinic one day weekly per PI schedule.Occasionally may be given research interns (typically high school or undergraduate) to assist with tasks depending on their availability.Minimum Qualifications
High School diploma or GED.Three years of relevant experience.Preferred Qualifications
Bachelor's degree in a related field. No experience required with preferred degree.Industry sponsored Clinical Trial ExperienceMust be experienced with Excel spreadsheets and research database use such as REDCap/OnCore/EDCs.Must have the ability to understand and implement patient studies and protocols.Ability to speak Spanish is a plus but not mandatory.Organized, self-motivated, can teamwork, works well under pressure, engages in multitasking.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Requisition ID: 21053