Summary
The Department of Neurology and the Parkinson's Disease Center and Movement Disorders Clinic provide educational programs to residents and fellows, medical students and practicing Neurologists; support research in Neurological disorders; offer the highest quality, and state-of-the-art facilities and equipment. We invite you to learn more about our nationally and internationally recognized physicians and our cutting-edge research.
The Parkison’s Disease Center & Movement Disorder Clinic is seeking an experienced Senior Research Coordinator who possesses advanced knowledge of clinical research practices. The Senior Research Coordinator will function in a capacity in which they coordinate and facilitate multiple clinical research trials.
The Senior Research Coordinator will provide professional skills involving patient-related research efforts. The ideal candidate is expected to perform responsibilities in a manner that promotes quality and safe patient care and customer service; adheres to the scope of practices as defined by the GCP/ICH guidelines.
This is a full-time position located at our McNair Campus, in the Texas Medical Center. Learn more about the Department of Neurology Parkinson's Disease Center and Movement Disorders Clinic by using the below link: www.Jankovic.org
Job Duties
- Coordinates multiple complex clinical research trials, ensuring all study activities are conducted in accordance with protocol requirements, institutional policies, Good Clinical Practice (GCP), and applicable regulatory guidelines. Serves as the primary contact for sponsors, monitors, and investigators during site initiation, interim monitoring, and closeout visits. Educates and informs participants regarding study procedures, expectations, and follow-up requirements. (20%)
- Oversees participant scheduling and operational flow across assigned trials, ensuring that all study-related tests and procedures (e.g., imaging, laboratory testing, and specialty assessments) are accurately coordinated, documented, and completed within protocol-defined timeframes. Works collaboratively with clinical and ancillary departments to minimize disruptions and optimize participant experience. (10%)
- Ensures proper collection, processing, shipment, and documentation of research specimens in accordance with protocol requirements and biosafety standards. Ensures chain-of-custody, sample integrity, and timely reporting of lab results. (2%)
- Maintains and audits regulatory and source documentation for assigned trials to ensure compliance with institutional, sponsor, and federal regulatory requirements. Reviews documentation prepared by junior staff for accuracy and completeness; identifies and addresses gaps proactively. (10%)
- Oversees investigational product management including receipt, storage, dispensing, reconciliation, and documentation in collaboration with the investigational pharmacy. Ensures compliance with sponsor and FDA requirements for drug accountability. (3%)
- Performs and oversees advanced clinical procedures as required by protocol, including venipuncture, EKGs/ECGs, vital sign collection, infusion line placement/removal, administration of investigational product (infusion or injection), and continuous monitoring of participants during study drug administration. Ensures team adherence to safety and aseptic standards. (30%)
- Conducts IRB-related activities, including preparation and submission of new study applications, amendments, continuing reviews, and reports of unanticipated problems. Serves as the departmental resource for IRB process navigation and submission strategy. (5%)
- Maintains investigational product dispensing and shipping logs in compliance with study protocols and institutional policies. Audits records for accuracy and completeness prior to sponsor review. (3%)
- Serves as the lead resource and mentor for junior research coordinators, providing training, guidance, and troubleshooting on study conduct, documentation, regulatory compliance, and participant management. Offers input on workflow optimization and operational efficiency across the team. (10%)
- Represents the research team in meetings with sponsors, CROs, and institutional leadership to address study progress, operational challenges, and compliance matters. Provides input on feasibility assessments for new studies and contributes to strategic planning of departmental research operations. (5%)
- Performs other related duties as assigned to support the success and compliance of the clinical research program. (2%)
Other
- Conducts detailed discussions with patients regarding study participation, including study purpose, procedures, potential risks and benefits, and patient rights. Obtains informed consent in compliance with FDA, IRB, and institutional requirements, and ensures thorough documentation of the consent process.
- Ensures the collection, review, and submission of clinical research data through paper and electronic case report forms (CRFs), ensuring data accuracy, consistency, and completeness. Oversees data query resolution and data integrity for assigned trials.
- Documents study encounters and activities in the electronic medical record (e.g., EPIC or equivalent), ensuring consistency between clinical and research documentation.
- Leads by example in fostering a culture of compliance, teamwork, and excellence in clinical research operations, contributing to process improvement and departmental efficiency.
Minimum Qualifications
- Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
- Five years of relevant experience.
Preferred Qualifications
- Master's degree in a related field.
- Advanced knowledge of clinical research and research processes preferred.
- Prior experience implementing complex patient studies and protocols.
- Effective communication skills, both orally and in writing.
- Interpersonal skills necessary to coordinate research studies.
- EPIC experience.
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.