Ohio State University
Senior Clinical Research Coordinator
Ohio State University, Columbus, Ohio, United States, 43215
Senior Clinical Research Coordinator
The Senior Clinical Research Coordinator is a leadership position focused on ALS clinical trials and studies only. The Sr. CRC serves as lead 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 Division of Neuromuscular in the Department of Neurology; 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. Minimum Education Required: Bachelor's Degree in biological sciences, health sciences or medical field or an equivalent combination of education and experience required. Minimum Experience Required: Three years' experience in a clinical research capacity conducting clinical research studies required. Clinical research certification from an accredited certifying agency required. Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen. Skills and Qualifications Desired/Preferred: Four to six years of clinical research experience preferred; experience in a progressively responsible management capacity in a medical research environment preferred; experience or knowledge in neurological movement disorders preferred; computer skills required with experience using Microsoft Software applications desired. Location:
Kenny Rd, 2006-2030 (0214) Position Type:
Regular Scheduled Hours:
40 Shift:
First Shift Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process. The university is an equal opportunity employer, including veterans and disability. As required by Ohio Revised Code section 3345.0216, Ohio State will: educate students by means of free, open and rigorous intellectual inquiry to seek the truth; equip students with the opportunity to develop intellectual skills to reach their own, informed conclusions; not require, favor, disfavor or prohibit speech or lawful assembly; create a community dedicated to an ethic of civil and free inquiry, which respects the autonomy of each member, supports individual capacities for growth and tolerates differences in opinion; treat all faculty, staff and students as individuals, hold them to equal standards and provide equality of opportunity with regard to race, ethnicity, religion, sex, sexual orientation, gender identity or gender expression.
The Senior Clinical Research Coordinator is a leadership position focused on ALS clinical trials and studies only. The Sr. CRC serves as lead 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 Division of Neuromuscular in the Department of Neurology; 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. Minimum Education Required: Bachelor's Degree in biological sciences, health sciences or medical field or an equivalent combination of education and experience required. Minimum Experience Required: Three years' experience in a clinical research capacity conducting clinical research studies required. Clinical research certification from an accredited certifying agency required. Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen. Skills and Qualifications Desired/Preferred: Four to six years of clinical research experience preferred; experience in a progressively responsible management capacity in a medical research environment preferred; experience or knowledge in neurological movement disorders preferred; computer skills required with experience using Microsoft Software applications desired. Location:
Kenny Rd, 2006-2030 (0214) Position Type:
Regular Scheduled Hours:
40 Shift:
First Shift Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process. The university is an equal opportunity employer, including veterans and disability. As required by Ohio Revised Code section 3345.0216, Ohio State will: educate students by means of free, open and rigorous intellectual inquiry to seek the truth; equip students with the opportunity to develop intellectual skills to reach their own, informed conclusions; not require, favor, disfavor or prohibit speech or lawful assembly; create a community dedicated to an ethic of civil and free inquiry, which respects the autonomy of each member, supports individual capacities for growth and tolerates differences in opinion; treat all faculty, staff and students as individuals, hold them to equal standards and provide equality of opportunity with regard to race, ethnicity, religion, sex, sexual orientation, gender identity or gender expression.