Clinical Research Coordinator

OhioHealth•Columbus, OH

18d

About The Position

The Clinical Consultant Research collaborates with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. The role performs day-to-day study activities, including recruiting and screening participants, obtaining informed consent, educating participants about study requirements, reporting events, collecting and organizing research data, and completing case report forms. Work is performed at a basic level under direct supervision across different types of clinical studies. The coordinator supports study planning and implementation, participant enrollment and visits, consent processes, documentation, and communication with participants, investigators, sponsors, and clinical teams. The role also assists with participant care, monitoring and audit readiness, reporting, records management, and required policy and compliance training. Responsibilities require attention to safety, quality, and efficiency as part of a High Reliability Organization. The job profile is an overview, not an exhaustive list, and may change.

Requirements

Bachelor's degree from a four-year college or university.
Ability to prioritize assigned work.
Strong verbal and written communication and customer service skills.
Ability to problem-solve, prioritize, and manage multiple tasks.
Strong computer skills, including thorough knowledge of EMR and Microsoft systems.

Nice To Haves

One year of relevant work or academic experience preferred.
Prior experience in a medical environment preferred.
Clinical Research Coordinator Certification or equivalent approved Clinical Research Certification.
One or more years of direct human subjects research experience.
Clinical knowledge in the assigned therapeutic area or program.

Responsibilities

Assist with implementing and coordinating research studies and projects; remain accountable to the PI for study-specific responsibilities.
Work with the PI and direct supervisor to organize and carry out research efficiently and on time.
Assist with protocol feasibility, resource planning, study planning, and internal training to implement protocols and avoid deviations.
Assist with participant recruitment and oversee clinical trial enrollment as directed by the PI.
Ensure study parameters are correctly applied before enrollment and during participant visits and assessments.
Extract and accurately record physical findings, laboratory data, and other study details on required data collection forms within designated timelines.
Attend investigator meetings, pre-study site visits, study initiation visits, and other study-related visits by monitors or sponsor representatives; some pre-study visits may require travel.
Participate in protocol meetings to review study procedures, staffing, and visit flow.
Participate in the informed consent process with the Investigator, ensuring participants and, when applicable, families have questions answered and understand the consent form and study responsibilities.
Instruct participants and serve as their primary contact for study-specific questions, concerns, or events.
Record and extract data from source documentation onto paper or electronic forms and maintain accurate, timely source documentation.
Prepare study documents for archiving after closeout visits, according to timelines.
Maintain in-depth knowledge of protocol requirements and GCP guidelines.
Assist nursing and clinical staff in facilitating participant care; observe and report adverse events and protocol violations or deviations promptly and accurately to the Investigator.
Assist with OHRI audit preparedness and study monitoring visits, including being available to address corrections and questions.
Maintain study records according to sponsor requirements and regulations, and keep records in a secure location.
Assist in developing reporting metrics, generate reports, review data validity, and provide ad hoc reports.
Communicate accurately and promptly; serve as a liaison between sponsors and investigators regarding study preparation, execution, and completion.
Adapt communication to different situations and communication barriers; demonstrate teamwork and use appropriate media to support communication.
Manage time, prioritize work, follow up on projects, and remain flexible across multiple projects.
Participate in meetings with OHRI, the PI, and clinical teams to review patient status, and work with research staff to communicate patient processes throughout each trial.
Advise, communicate, and reinforce standard practices and regulations relating to research study participation.
Attend relevant policy and compliance training, complete assigned training and position requirements, and maintain familiarity with evolving regulatory and compliance requirements.
Perform other duties as assigned or required.