Senior Clinical Research Coordinator - CCC | Clinical Trials Office

The Ohio State University • Columbus, OH

1d • Onsite

About The Position

Senior Clinical Research Coordinator serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the Phase I Program in the Clinical Trials office; oversees, implements & coordinates conduct of daily activities of research studies; serves as primary reviewer of patient records to assess and identify patients who meet criteria for participation in research studies; 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; facilitates collection, processing & evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing; 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; participates in collecting, extracting, coding, and analyzing clinical research data; assists with activities to ensure compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; participates in planning, organizing and preparing for external compliance and quality assurance and control reviews; actively participates in internal quality assurance audits; participates in development of new research protocols and contributes to planning of goals to meet study requirements; assists with preparation and submission of publications, research reports, and grant proposals.

Requirements

• Bachelor’s Degree in biological sciences, health sciences or medical field or an equivalent combination of education and experience required.
• Three to five years experience in a clinical research capacity conducting clinical research studies required.
• Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) required.
• Computer skills required with experience using Microsoft Software applications desired.

Nice To Haves

• Experience in a progressively responsible management capacity in a medical research environment preferred.
• Experience or knowledge in specialty area preferred.

Responsibilities

• Serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the Phase I Program in the Clinical Trials office.
• Oversees, implements & coordinates conduct of daily activities of research studies.
• Serves as primary reviewer of patient records to assess and identify patients who meet criteria for participation in research studies.
• 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.
• Facilitates collection, processing & evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing.
• 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.
• Participates in collecting, extracting, coding, and analyzing clinical research data.
• Assists with activities to ensure compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations.
• Participates in planning, organizing and preparing for external compliance and quality assurance and control reviews.
• Actively participates in internal quality assurance audits.
• Participates in development of new research protocols and contributes to planning of goals to meet study requirements.
• Assists with preparation and submission of publications, research reports, and grant proposals.

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