Clinical Research Coordinator

Overview

The Clinical Research Coordinator will support clinical research studies conducted in the Department of Emergency Medicine. Research personnel will screen and recruit potential participants in the emergency department and other clinical settings, conduct informed consent, and perform study procedures in accordance with approved protocols. The Research Coordinator will work across federally and industry-funded studies involving patient screening, enrollment, data collection, biospecimen handling, and follow-up visits. Study procedures may include blood draws, hemodynamic monitoring, sample collection and processing, and shipment of specimens as specified by study protocols. Training will be provided for all protocol-specific procedures before independent execution. Meticulous documentation, adherence to human subjects regulations, and strict compliance with study protocols are essential for this role.

Key Responsibilities

• Screen, recruit, and enroll study participants in clinical settings according to protocol-defined eligibility criteria.
• Conduct informed consent and ensure ethical and regulatory compliance for human subjects research.
• Perform study procedures, including blood draws, sample processing, hemodynamic monitoring, and study intervention support.
• Coordinate and conduct study visits and follow-up activities, including remote and home visits when required by protocol.
• Accurately collect, document, and enter study data into electronic data capture systems.
• Maintain study records and regulatory documentation in compliance with institutional and sponsor requirements.
• Assist with preparation and submission of IRB/HIC documents, amendments, and continuing reviews.
• Support study start-up activities, including preparation of study materials and workflow coordination.
• Order, organize, and maintain research supplies and study inventory.
• Communicate effectively with investigators, clinical staff, sponsors, and study teams.
• Assist in preparation of study reports, presentations, abstracts, and manuscripts.
• Perform other study-related duties as assigned.

Required Skills and Abilities

1. Proven experience with clinical studies. Maintains compliance with all relevant regulations throughout the research process. Proven experience obtaining informed consent.
2. Strong organizational skills and attention to detail. Ability to work independently while maintaining close coordination with the research team.
3. Proven ability to work efficiently and independently under pressure, prioritizing tasks effectively.
4. Excellent communication and interpersonal skills.
5. Willingness to support study activities with a degree of scheduling flexibility, which may include occasional evening, weekend, or off-hours coverage based on study needs.

Principal Responsibilities

1. Serves as the primary oversight specialist on clinical and operational processes for low to moderately complex studies and non-therapeutic trials. Serves as a supporting clinical research coordinator to CRC/CRN II and Sr. CRC/CRN for highly complex protocols.
2. Manages, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration for low to moderately complex studies and non-therapeutic trials.
3. Contributes to study feasibility reviews and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH/GCP, federal regulation, and institutional processes for low to moderately complex clinical trials and non-therapeutic trials.
4. Ensures low to moderately complex study protocols are adhered to, oversees the maintenance of accurate documentation, recruitment of study participants and ensures regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements.
5. Identifies instances of noncompliance and deviations from protocol and works with manager to analyze and advises noncompliance and deviations to the appropriate parties.
6. Advises Principal Investigator oversight on low to moderately complex clinical trials and non-therapeutic trials by providing updates on protocol issues, status of signatures and clinical significance on lab reports, ECGs, adverse events and other documents as required.
7. Analyses, documents and conveys study data on low to moderately complex clinical trials and non-therapeutic trials. Coordinates with assigned staff to oversee and ensure that report forms are accurately documented and completed in a timely manner.
8. Oversees the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations on low to moderately complex clinical trials and non-therapeutic trials.
9. Assesses trial execution for assigned low to moderately complex trials and non-therapeutic trials and identifies areas that need improvement or that require correction and provides education and/or recommendations, as needed.
10. Collaborates with Investigators and Research Managers in the preparation and execution of corrective and preventative action plans and ensures implementation and adherence to stated plan for low to moderately complex trials and non-therapeutic trials. 
11. Collaborates with the Quality Education Unit to contribute to the design of CRC trainings and continuing education.
12. Participates in interim monitoring visits and internal audits.
13. Monitors, interprets, and communicates federal and state regulations, and local policies for new guidance, updates, or policies. 
14. Performs other duties as assigned.

Required Education and Experience

Bachelor’s degree in a health-related discipline, or other related field and one (1) year of clinical research experience, or the equivalent combination of education or experience. Knowledge of Good Clinical Practices (GCP) and Federal Regulations is required.  Experience must indicate the ability to work with minimal supervision in a team environment.