Clinical Research Coordinator- Pulmonary Critical Care and Sleep

The Ohio State University•Columbus, OH

1d•Onsite

About The Position

Clinical Research Coordinator to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the non-cancer College of Medicine (COM) Center for Clinical Research Management (CCRM) for the Critical Care Trials Group in the Division of Pulmonary Critical Care in the Department of Internal Medicine. Assists with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols; recruits, interviews and enrolls patients; obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements; educates patients and families of purpose, goals, and processes of clinical study; coordinates scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing in accordance with study protocol; participates in the collection, processing & evaluation of biological samples; administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires; assists with monitoring 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 evaluating patients for compliance related to protocol; assists with collecting, extracting, coding, and analyzing clinical research data; generates reports and reviews to ensure validity of data; supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; assists with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; participates in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements.

Requirements

Bachelor’s Degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education and experience.
1 year of relevant experience required.
Proficient computer skills, including experience with Microsoft applications.

Nice To Haves

2-4 years of relevant experience preferred.
Experience or knowledge in the relevant specialty area is preferred.
Familiarity with medical terminology is desired.
Clinical research certification from an accredited agency is considered an asset.

Responsibilities

Assesses patient records to identify eligible participants for clinical research protocols.
Recruits, interviews, and enrolls patients into studies.
Obtains informed consent and ensures compliance with regulatory and sponsor requirements.
Educates patients and families about the study's purpose, goals, and processes.
Coordinates patient care appointments, procedures, and diagnostic testing according to the study protocol.
Collects, processes, and evaluates biological samples.
Administers, evaluates, and calculates standardized scores for diagnostic, psychological, or behavioral testing/questionnaires.
Monitors patients for adverse reactions and notifies appropriate clinical professionals.
Documents unfavorable responses and notifies research sponsors and regulatory agencies.
Evaluates patient compliance with the protocol.
Collects, extracts, codes, and analyzes clinical research data.
Generates reports and reviews data for validity.
Ensures compliance with IRB, FDA, federal, state, and industry sponsor regulations.
Coordinates and prepares for external quality assurance and control reviews.
Participates in developing new research protocols and establishing study goals.