Clinical Research Coordinator- Infectious Diseases

The Ohio State University

4d • Onsite

About The Position

The Lead Clinical Research Coordinator serves as the primary resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the non-cancer Center for Clinical Research Management (CCRM) for the Department of Internal Medicine, Division of Infectious Diseases. This role plans, implements, and oversees the daily conduct of protocol activities. The coordinator is the primary reviewer of patient records to assess and identify patients who meet criteria for participation in research studies, recruits, interviews, and promotes studies to eligible patients, and educates patients and families about the purpose, goals, and processes of the clinical study. They lead patient enrollment activities and ensure informed consent authorization is obtained and administered in compliance with regulatory and sponsor requirements. The role facilitates the collection, processing, and evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, and other diagnostic testing. The coordinator monitors patients for adverse reactions to study treatment or medication and notifies the appropriate clinical professional to evaluate patient response, identify the status of complications, and provide the appropriate level of care. They document unfavorable responses and notify research sponsors and applicable regulatory agencies. The position participates in collecting, extracting, coding, and analyzing clinical research data, and monitors and ensures compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state, and industry sponsor regulations. The coordinator participates in planning and preparing for external compliance, quality assurance, and control reviews. They also participate in the development of new research protocols and contribute to the planning of goals to meet study requirements. The role works closely with principal investigators upon awarding of new protocols and recommends team assignments. Additionally, the coordinator assists with the preparation and submission of publications, research reports, and grant proposals. They train, mentor, approve timesheets, assist with annual Buckeye Performance goals and performance, and supervise staff.

Requirements

• Must have a background check
• May require a drug screen or physical during the post offer process

Responsibilities

• Plans, implements & oversees daily conduct of protocol activities
• Determines, coordinates & assigns clinical research tasks to research team
• Oversees, evaluates and revises processes to identify, recruit and enroll patients into clinical studies
• Serves as primary reviewer of patient records including new patient admissions or readmissions, outpatient and/or emergency room visits to assess and identify patients who may meet criteria to be considered for inclusion in a clinical research study
• Recruits, interviews and promotes study to eligible patients
• Educates patients and families of purpose, goals, and processes of clinical study
• Leads patient enrollment activities and ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements
• Ensures initial and follow-up appointments are appropriately scheduled and fulfilled for participants to receive patient care services according to protocol
• Facilitates collection, processing & evaluation of biological samples, as well as scheduling and coordinating medical procedures & diagnostic testing
• Develops and establishes rating scales for standardized scoring of diagnostic, psychological, or behavioral testing or questionnaires
• Evaluates and calculates scoring of administered diagnostic, psychological or behavioral testing or questionnaires
• Assesses risk to benefit ratios
• Coordinates and documents care of patients
• Participates in evaluating patients for compliance related to protocol
• Monitors patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care
• Documents unfavorable responses and notifies research sponsors & applicable regulatory agencies
• Facilitates team meetings and disseminates information
• Serves as liaison between CCRM, investigators and sponsors
• Participates in collecting, extracting, coding, and analyzing clinical research data
• Reviews research data to ensure validity and discover inconsistent or inaccurate data
• Assists with development of clinical research study database
• Compiles and enters clinical research data into study database
• Generates reports
• Assists with writing manuscripts & articles for publication and presentation
• Participates in development of new research protocols and contributes to planning of goals to meet study requirements
• Assists Principal Investigator with preparation and submission of national and local grant submissions to secure continued and additional funding of clinical research projects
• Works closely with principal investigators upon awarding of new protocols and recommends team assignments
• Assists with planning and development of clinical study processes
• Prepares and submits regulatory documents to applicable governing agency related to the conduct of human subject research
• Supports activities, monitors & ensures compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations
• Prepares and participates in study monitoring activities
• Participates in planning, organizing and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors
• Actively participates in internal quality assurance audits
• Completes case report forms
• Participates in interviewing and selection of clinical research staff
• Trains, mentors and supervises staff
• Assists with P3 goals and performance management
• Approves timesheets
• Attends departmental meetings
• Attends national professional and scientific conferences to continue professional development
• Completes special projects as required

Benefits

• Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost.
• Paid time off, including sick and vacation time and 11 holidays.
• State retirement plan or an alternative retirement plan, both with generous employer contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed