Clinical Research Coordinator

The Ohio State University

1d•Onsite

About The Position

The Clinical Research Coordinator coordinates and performs daily clinical research activities for the Neuromuscular-ALS Division in the Department of Neurology. The work is conducted in accordance with approved protocols administered by the non-cancer Center for Clinical Research Management (CCRM). The coordinator supports participant identification, recruitment, interviews, enrollment, and informed-consent processes; educates patients and families about clinical studies; and coordinates appointments, procedures, and diagnostic testing. The role also involves collecting, processing, and evaluating biological samples; administering and scoring standardized assessments; monitoring for adverse reactions and escalating concerns to clinical professionals; documenting unfavorable responses and notifying sponsors and regulatory agencies; and evaluating protocol compliance. The coordinator assists with clinical research data collection, extraction, coding, analysis, reporting, and validation. The position supports compliance with IRB, FDA, federal, state, and sponsor regulations, helps prepare for external quality assurance and control reviews, and participates in developing protocols and study goals. This is a patient-facing position required to be onsite daily, with possible travel to other clinical research locations in the Columbus metropolitan area and to University Hospital Main Campus.

Requirements

Bachelor’s degree in Biological Sciences, Health Sciences, Social Sciences, or another medical field, or an equivalent combination of education and experience.
At least 1 year of relevant experience.
Computer skills.

Nice To Haves

2–4 years of relevant experience.
Experience or knowledge in neurological diseases and disorders.
Knowledge of medical terminology.
Experience using Microsoft software applications.
Clinical research certification from an accredited certifying agency, such as ACRP or SOCRA.

Responsibilities

Coordinate and perform daily clinical research activities in accordance with approved protocols.
Assess patient records to identify individuals eligible for clinical research protocols.
Recruit, interview, and enroll patients.
Obtain informed consent and ensure consent procedures comply with regulatory and sponsor requirements.
Educate patients and families about the purpose, goals, and processes of clinical studies.
Coordinate patient-care appointments, procedures, and diagnostic testing according to study protocols.
Participate in collecting, processing, and evaluating biological samples.
Administer, evaluate, and calculate standardized scores for diagnostic, psychological, or behavioral tests and questionnaires.
Help monitor patients for adverse reactions to study treatments, procedures, or medications, and notify appropriate clinical professionals to evaluate patient responses and provide appropriate care.
Document unfavorable responses and notify research sponsors and applicable regulatory agencies.
Participate in evaluating patient compliance with protocols.
Assist with collecting, extracting, coding, and analyzing clinical research data; generate reports and review data for validity.
Support compliance with IRB, FDA, federal, state, and industry sponsor regulations.
Assist with coordinating and preparing for external quality assurance and control reviews by IRB, federal agencies, or industry sponsors.
Participate in developing new research protocols and establishing study goals to meet protocol requirements.