Job Description
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Job Title: Research Coordinator II - Medicine - Pulmonary
Division: Medicine
Work Arrangement: Onsite only
Location: Houston, TX
Salary Range: $47,372 - $55,731
FLSA Status: Nonexempt
Work Schedule: Monday - Friday, 8 a.m. - 5 p.m.
Summary
The Pulmonary, Critical Care & Sleep Medicine Research team is seeking an experienced Research Coordinator II to manage and coordinate clinical research studies from startup through closeout. Responsibilities include participant screening and enrollment, study visits, data collection, regulatory compliance, study documentation, sponsor communication, and coordination of clinical trial activities. The coordinator will work closely with Principal Investigators, clinical teams, sponsors, contract research organizations (CROs), laboratories, and research partners to ensure studies are conducted according to protocol, institutional requirements, and applicable regulations.
This position supports a diverse portfolio of clinical trials and requires experience coordinating research studies in a hospital, academic, or clinical research setting. The successful candidate will have a strong understanding of the clinical trial lifecycle, including study startup, enrollment, study conduct, monitoring visits, and closeout activities. Responsibilities also include maintaining regulatory and study documentation, managing study data and CTMS records, tracking milestones and sponsor deliverables, and developing workflows that support efficient study operations.
Candidates should have prior clinical trial experience, familiarity with clinical trial management systems (CTMS) and electronic research platforms, and a working knowledge of medical terminology. Strong organizational, project management, communication, and problem-solving skills are essential, as is the ability to independently manage multiple priorities while maintaining participant safety, protocol compliance, data quality, and study timelines.
The ideal candidate is a collaborative and proactive professional who takes ownership of assigned studies, communicates effectively with patients, healthcare professionals, sponsors, and research partners, and can identify and resolve study-related challenges. Experience with wearable technology is a plus. An interest in pulmonary, critical care, and sleep medicine research is strongly preferred.
Job Duties
- Study Compliance and Coordination - 10%: Ensures assigned studies are conducted in compliance with protocols, IRB requirements, sponsor expectations, and applicable regulations. Coordinates study activities from startup through closeout and addresses operational issues that may impact timelines, compliance, or participant safety.
- Clinical Trial Management - 10%: Coordinates multiple clinical research studies and manages study timelines, deliverables, and daily operations. Reviews protocols and study documents to understand study objectives, procedures, eligibility criteria, and visit requirements.
- Participant Recruitment and Enrollment - 10%: Identifies and screens potential participants, supports recruitment efforts, obtains informed consent as applicable, and educates participants regarding study procedures and expectations.
- Participant Visits and Data Collection - 15%: Coordinates and conducts study visits and protocol-required activities. Collects, documents, and enters accurate study data into electronic systems and research databases. Assists with clinical procedures within the scope of training and institutional guidelines.
- Specimen Management - 5%: Collects, processes, stores, and ships biological specimens according to protocol and laboratory requirements. Maintains accurate specimen documentation and chain-of-custody records.
- Regulatory Documentation - 15%: Maintains regulatory and essential study documents, including IRB submissions, approvals, amendments, consent forms, study logs, training records, and safety documentation. Supports audits, inspections, and monitoring visits.
- CTMS and Data Management - 10%: Updates CTMS and other research systems with participant, visit, enrollment, and study milestone information. Reviews data for completeness and accuracy and resolves data discrepancies.
- Study Coordination - 10%: Coordinates participant appointments, laboratory testing, procedures, and other protocol-required activities. Tracks outstanding items and follows up to ensure study timelines and deliverables are met.
- Sponsor and Study Team Communication - 5%: Serves as a primary contact for sponsors, CROs, vendors, investigators, and internal research staff. Participates in study meetings and communicates updates, action items, and study concerns.
- Protocol Updates and Safety Reporting - 5%: Assists with implementation of protocol amendments, safety communications, and study updates. Supports reporting of adverse events, protocol deviations, and other required study documentation.
- Other Duties - 5%: Performs additional research and administrative duties as assigned, including study startup activities, feasibility assessments, monitoring visits, investigator meetings, and quality improvement initiatives.
Minimum Qualifications
- Bachelor''s degree in a related field. Four years of related experience may substitute for degree requirement.
- One year of relevant experience.
Preferred Qualifications
- At least one year of relevant clinical research experience preferred.
- Substantial experience coordinating clinical trials strongly preferred.
- Clinical or medical experience, preferably in pulmonary, critical care, sleep medicine, or a related specialty.
- Familiarity with CTMS and electronic data capture (EDC) systems.
- Knowledge of clinical trial procedures and regulatory requirements.
- Experience communicating with study sponsors and contract research organizations (CROs).
- Strong organizational and time management skills.
- Excellent written and verbal communication skills.
- Demonstrated problem-solving and critical thinking abilities.
- Strong project management skills with the ability to manage multiple studies simultaneously.
- Ability to work independently while also collaborating effectively with multidisciplinary teams.
Work Authorization Requirement:
This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Requisition ID: 26676
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