Summary

The Senior Research Coordinator role provides direct oversight to fast-paced and detailed therapeutic/interventionaldrug and device clinical research trials at BCM and affiliates, across a variety of disease areas. This position willdevelop, implement, and coordinate clinical research and logistical procedures for the successful management ofclinical trials. The Sr. Research Coordinator will perform clinical research duties requiring analysis, sound judgment,critical thinking skills, and a high level of knowledge of study specific protocols.

Job Duties

• Clinically and administratively manages an average of one or more clinical trials based on complexity. Oversees theday-to-day activities including screening, enrollment, and monitoring of research participants.
• Develops new processes, procedures, tools and training to enhance clinical research activities and conducts qualityassurance / quality control checks of the work of others.
• Ensures that non-serious and serious adverse events are properly documented and reported to internal and externalagencies as needed per protocol requirements and federal guidelines.
• Trains lower-level clinical research personnel regarding scientific aspects of studies, study setup, enrollment,recruitment, EMR transactions, ongoing management of clinical research protocol activities, and SOPs.
• Completes and maintains case report forms per FDA guidelines, and reviews against patient medical records forcompleteness and accuracy; participates in the quality assurance process, attends monitoring meetings with sponsors.
• Leads study feasibility by completing a comprehensive review of protocol and study logistics such as staffing resources,patient population, and clinical resources needed to correctly conduct study.
• Leads, organizes and participates in pre-site and site initiation visits; coordinates study initiation; completes in-servicesfor hospital nurses and physicians in clinical areas involved in conduct of study to outline logistics and needs of study.
• Independently interviews, screens and recruits patients for study; explains process and procedures to educateparticipant regarding the research study; verifies eligibility of patients for enrollment in study.
• Adheres to FDA Good Clinical Practices outlining the standard for design, conduct, performance, monitoring, auditing,recording, analysis and reporting of clinical trials or studies.
• Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials.
• Leads and conducts reviews on on-going studies and oversees quality assurance on ongoing protocols.
• Acts as liaison between the Principal Investigator and patients.
• Collaborates with clinical research team by actively communicating and reporting pertinent information as needed andparticipating in clinical research meetings.

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.
• Clinical trials experience.
• Familiar with the following database search engines may be needed: PubMed, Medline, CINAHL, Cochrane,EMBASE, Nursing Consult, AHRQ and other EBP websites.
• Reliability and flexibility to meet pre-determined deadlines is essential, as well as the ability to interact affably withphysicians, residents, and staff.