Job Description

About the Job

The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations and study protocol guidelines, monitor study participants, and take a proactive approach to identify issues throughout the clinical research process.

Primary Responsibilities

• Demonstrate autonomy in protocol execution, regulatory compliance, and study leadership while effectively communicating with study sponsors, CROs, monitors/CRAs, IRBs, laboratories, and clinical personnel.
• Independently identify, analyze, and resolve study-related challenges, including protocol deviations, data discrepancies, and logistical issues. Proactively develop solutions to ensure compliance with study protocols, regulatory requirements, and site-specific procedures while escalating complex issues as needed.
• Support leadership activities, including training, mentoring, and assisting with complex site challenges.
• Maintain a strong and evolving understanding of study protocols and procedures.
• Identify and troubleshoot issues related to patient enrollment, protocol deviations, and study compliance; escalate complex cases to investigators or site leadership when appropriate.
• Manage and document Adverse Events (AEs) and Serious Adverse Events (SAEs) in compliance with regulatory and sponsor requirements, ensuring timely follow-up and resolution.
• Handle complex subject situations, including retention challenges, non-compliance, and withdrawal decisions, in collaboration with the Principal Investigator (PI).
• Maintain strong knowledge of FDA regulations, ICH-GCP guidelines, and IRB processes.
• Understand and implement Standard Operating Procedures (SOPs).
• Develop knowledge of investigational products used in clinical trials.
• Serve as a resource on assigned studies to guide team members on protocols and procedures.
• Establish and maintain rapport with study participants.
• Perform clinical data collection (e.g., vital signs, EKGs, height, weight).
• Obtain and review medical records as required.
• Perform phlebotomy and manage specimen collection, processing, storage, and transport.
• Educate participants on study requirements, including diary completion, medication restrictions, and visit expectations.
• Conduct patient follow-up calls according to study protocols.
• Ensure documentation meets ALCOA standards and is completed accurately and on time.
• Ensure all required documents are properly completed, signed, and dated.
• Provide required information to CROs, IRBs, sponsors, regulatory agencies, and other stakeholders as needed.
• Manage study inventory and order supplies.
• Prepare for and assist with monitoring visits.
• Maintain awareness of all ongoing clinical research studies.
• Travel to investigator meetings as required.
• Support team operations by working flexible hours and assisting with tasks outside routine responsibilities when needed.
• May require occasional weekend and/or overtime work.
• Perform other duties as assigned.

Desired Skills and Qualifications

• 2–3 years of clinical research experience.
• Completion of formal medical training, an educational program, or relevant healthcare experience.
• Strong knowledge of medical terminology.
• Ability to perform clinical, laboratory, and diagnostic procedures (e.g., vital signs, height, weight, temperature).
• Ability to work independently and take ownership of study-related responsibilities.
• Strong multitasking skills in a fast-paced, evolving environment.
• Excellent listening, written, and verbal communication skills.
• Proficiency with office equipment and standard software programs.
• Strong organizational and time management skills.
• Ability to remain active for most of the workday.
• Ability to lift, transfer, push, and handle equipment or assist patients, requiring physical strength and coordination.
• Fluency in English.

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