Summary

Unique opportunity to provide centralized coordinator support within the Office of Clinical Research (OCR) to multiple Principal Investigators (PIs) across the College and its affiliates. Position supports clinical trial support on both therapeutic drug and device trials in varying disease areas with multiple departments. This role is essential for coordination of the OCR research portfolio, liaising with PIs, regulatory staff, sponsor representatives, investigational pharmacy, and provides cross-coverage across the OCR team. Position supports clinical research trial support across BCM and its affiliates.(outside of Monday-Friday, 8:00 am to 5:00 pm).

Job Duties

• Clinically and administratively manages day to day activities multiple complex clinical research protocols or studies including therapeutic and interventional clinical trials
• Recruits, schedules and conducts the daily activities of clinical research participants, liaising with investigators and regulatory staff. Attends regular staff meetings; provides training and guidance on regulations and best practices to new coordinators
• Collects, process, ships and maintain paper work for blood and biological specimen according to procedures outlines in study.
• Complete and maintain case report forms per FDA guidelines, and review against patient medical record for completeness and accuracy; participates in quality assurance process, attends monitoring meetings with sponsors.
• Interfaces with study sponsors, monitors and interprets safety data, and reports serious adverse events (SAE) in timely manner
• Implements effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials *May oversee the work and assist in the training of Research Coordinators *Serves as a senior individual contributor on research projects within the team. *Collects, evaluates, and interprets research data to provide needed information to principal investigators and other researchers.
• Assists with research portfolios for numerous PIs and departments across the College.
• Participates in study qualification and study feasibility activities for report to research manager.
• Liaises with PI, Sponsor, Research Manager and OCR Research Finance to support all aspects of study activity.
• Supports research manager and investigators with timely reporting of study status, enrollment status, study monitoring, and site visits.
• Liaises with Research Manager, PI, Sponsor for timely scheduling and coordination of pre-site and site initiation visits
• Attends regular meetings with Research Manager, PIs, and study team for update reports and process improvement
• Follows departmental and institutional standard operating procedures (SOPs). Participates in quality control reviews of study activities and chart reviews
• Completes data collection, documentation activities and database queries
• Coordinates research protocol procedures and processes, working closely with Research Manager, study team, and OCR Regulatory team on monitoring visit report findings
• Provides cross-coverage on study activities across OCR as needed
• Participates in additional projects as directed by research manager, as a central office within the Office of Research

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.