Clinical Research Coordinator

Requirements

• Required: Three (3) years current experience in acute care hospital, medical center, health system or related industry
• Preferred: Previous experience with clinical trials
• Reports To: Manager-Research and Clinical Trials
• Supervises: N/A
• Ages of Patients: Adult, Geriatric
• Blood Borne Pathogens: Moderate Potential
• Skills, Knowledge, Abilities:
• Essential Responsibilities
• Demonstrates compliance with Code of Conduct and compliance policies and takes action to resolve compliance questions or concerns and report suspected violations.
• Recruits, educates, consents, schedules, and completes follow-up with patients/subjects.
• Participates in the design, planning and conduct of clinical trials program and clinical research projects.
• Performs pre-investigation, initiation and periodic monitoring visits to assure that the protocol, obligations, responsibilities, and regulations are established and followed.
• Monitors subject records for quality, data integrity and compliance with regulations and organization's standard operating procedures (SOP).
• Assists in writing and/or auditing clinical reports.
• Assists in developing protocols, case report forms, and informed consent documents.
• Works closely and acts as a liaison between sponsors, Contract Research Organization (CRO) sites and other department staff members.
• Manages the negotiation and monitoring of budgets and contracts; formulates study budgets utilizing the protocol, manuals, study plan and resource needs assessment for the study; develops and supports the development of tools and training to aid in the development of study budgets, coverage analysis, tracking of invoiceable term items and research billing.
• Performs clinical site activities (regulatory issues, patient accrual, patient scheduling and care coordination, data capture and monitoring, adverse events reporting).
• Develops sufficient service/ program / product / indication expertise to communicate directly with clinicians, staff, other departments, consultants and provide consultation/expert advice to leadership.
• Develops or contributes to the development of SOPs, best practices, tools, processes and training to enhance safety and compliance with federal, local and institutional regulations/guidelines.
• Manages tracking and reporting Serious Adverse Events (SAEs) and Adverse Events (AEs).
• Works with physicians and leadership to develop and implement client trials and research programs; carries out key activities in evaluating, initiating, operationalizing and conducting clinical trials.
• Works closely with physicians and staff to facilitate research and enrollment to research studies and clinical trials.
• Prepares and presents materials to Institutional Review Board (IRB); investigates and resolves problems and complaints; develops corrective and preventative action plans.
• Develops educational/promotional materials to educate patients on available programs and clinical trials; develops and maintains a formal mechanism to ensure that information about the availability of clinical trials is provided to patients.
• Works to accrue and monitor cases enrolled in program and clinical trials; reports to governing Committee.
• Coordinates performance improvement activities as they relate to clinical trials and research.
• Provides support to investigators and maintain screening, enrollment, compliance, statistics on program and trials. Involved in planning lon

Benefits

Additional Information

Default Work Shift: Varies (United States of America) Hours: 40 Salary range: $33.73 - $51.24 Schedule: Full Time Shift Hours: 8 Hour employee Department: Research-Cardiology Job Objective: Coordinates and implements clinical research activities. Job Description: Education: Required: Bachelor's degree in healthcare and/or related field; completion of following CITI Program courses within 30 days of hire: Good Clinical Practice (GCP) Course, Clinical Research Coordinator Foundations Course, Clinical Research Coordinator Advanced Course; courses must be renewed in accordance with institutional policy Preferred: Master's degree Licensure/Certification: Preferred: ACRP CCRC or SOCRA CCRP Certification; certification required upon eligibility

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