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Senior Clinical Research Coordinator - $1500 Sign-on Bonus!

Location
Columbus, Ohio
Job Type
Permanent
Posted
5 Aug 2022
Job Description Summary

Senior Clinical Research Coordinator serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the non-cancer Clinical Trials Management Organization for the Department of Emergency Medicine; 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.

Essential Duties

60%: Plans, implements, coordinates and performs daily clinical research activities in accordance with approved protocols; 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; 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.

15%: 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.

10%: Participates in planning and developing of new clinical research projects; assists Principal Investigator with preparation and submission of national and local grant submissions to secure continued and additional funding of clinical research projects; contributes to development of plans to meet requirements of new clinical trials; assists with planning and development of clinical study processes.

10%: Prepares and submits regulatory documents to applicable governing agency related to the conduct of human subject research; supports activities to ensure 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; completes case report forms.

5%: Attends departmental meetings; attends national professional and scientific conferences to continue professional development; completes special projects as required.

Minimum Education and Skills/Experience Required/Desired

Bachelor s Degree in biological sciences, health sciences or other relevant 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; experience in a progressively responsible management capacity in a medical research environment preferred; experience or knowledge in Emergency Medicine preferred; clinical research certification from an accredited certifying agency required; computer skills required with experience using Microsoft Software applications desired. Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.

Regular 40 First Shift
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