Clinical Research Coordinator - Internal Medicine; Pulmonary, Critical Care, and Sleep Medicine

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** Job Description

Summary:

** The Clinical Research Coordinator (CRC) in the Division of Pulmonary, Critical Care, and Sleep Medicine is responsible for coordinating and managing clinical research studies in accordance with regulatory requirements and institutional policies. This role involves the planning, implementation, and oversight of research protocols, ensuring compliance with FDA regulations, GCP guidelines, IRB approvals, and HIPAA requirements. The CRC will collaborate with investigators, sponsors, and participants to facilitate all aspects of study conduct, including subject recruitment, informed consent, data collection, and reporting.##

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* Job Description:

**** Job Duties
**** Study Coordination & Management:
*** Coordinate multiple clinical research studies, including investigator-initiated and industry-sponsored trials.
* Develop and maintain study-specific documents, including regulatory binders, case report forms, and data collection tools.
* Ensure research protocols are conducted in accordance with IRB, FDA, NIH, and institutional regulations.
* Monitor study progress, ensuring adherence to timelines and compliance with protocols.
** Patient Recruitment & Enrollment:
*** Identify and screen eligible participants for clinical studies based on protocol inclusion/exclusion criteria.
* Obtain informed consent and educate participants about study procedures, risks, and benefits.
* Schedule study visits, follow-ups, and coordinate necessary clinical assessments.
** Data Collection & Regulatory Compliance:
*** Collect and enter accurate research data into electronic data capture (EDC) systems.
* Maintain compliance with Good Clinical Practice (GCP) and institutional policies.
* Prepare and submit regulatory documents to IRB and sponsor organizations.
* Assist in audits, monitoring visits, and responses to queries from regulatory agencies.
** Clinical & Laboratory Responsibilities:
*** Coordinate sample collection, processing, and shipping according to study requirements.
* Assist with study-related procedures such as pulmonary function tests, sleep studies, and vital sign monitoring under supervision.
* Ensure investigational products (drugs, devices) are handled per protocol and regulatory requirements.
** Collaboration & Communication:
*** Act as a liaison between study sponsors, investigators, patients, and healthcare providers.
* Participate in research team meetings, sponsor calls, and professional development sessions.
* Provide education and training to new research personnel and clinical staff as needed.  This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments.

Furthermore, job duties, responsibilities and activities may change at any time with or without notice.  
** Work Environment:
*** Evening hours may occasionally be required.
* Position is primarily based on-site.  
** Required Qualifications
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* Work Experience:

*** Four (4) years of experience in health sciences, nursing, biology, or related field. Education may be substituted for experience on a year for year basis.
* Two (2) years of clinical research experience.
* Experience with clinical research regulations (FDA, GCP, IRB, HIPAA).  
** Preferred Qualifications
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* Certifications:

** Phlebotomy certification.
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* Work Experience:

*** Four (4) years of clinical research experience.
* Experience in pulmonary, critical care, or sleep medicine research.
* Experience with REDCap, Epic, or similar data management systems.  
** Skills
* ** Organization.
* Problem-solving.
*…