Clinical Research Coordinator- Infectious Diseases

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Job Title:

Clinical Research Coordinator- Infectious Diseases

Department:

Medicine | IM Infectious Diseases

Lead Clinical Research Coordinator serves as 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; plans, implements & oversees daily conduct of protocol activities; serves as primary reviewer of patient records to assess & identify patients who meet criteria for participation in research studies; recruits, interviews & promotes study to eligible patients; educates patients and families of purpose, goals, & processes of clinical study; leads patient enrollment activities & 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 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, & analyzing clinical research data; monitors & ensures compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state & industry sponsor regulations; participates in planning and preparing for external compliance, quality assurance & control reviews; participates in development of new research protocols and contributes to planning of goals to meet study requirements; works closely with principal investigators upon awarding of new protocols and recommends team assignments; assists with preparation and submission of publications, research reports, and grant proposals; trains, mentors, approves timesheets, assists with annual Buckeye Performance goals and performance, and supervises staff.

Additional Information:

Essential Duties
60%: 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.

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 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.

10%: 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.

5%: 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.
 

Location:

McCampbell Hall (0303)

Position Type:

Regular

Scheduled Hours:

40

Shift:

First Shift

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