Clinical Research Coordinator

This is a fully remote position, open to applicants in Ohio.

📋 Description

• Oversee, execute, and manage low-workload, low-complexity research projects involving human subjects.

• Maintain essential regulatory documentation, binders, study data, IRB submissions, and research records.

• Fill out Serious Adverse Event reports, safety logs, FDA forms, sponsor updates, and other protocol-related documentation as necessary.

• Liaise with sponsors, monitors, research personnel, and both internal and external stakeholders to ensure compliance with study protocols.

• Organize pre-site selection, site initiation, monitoring, webinars, and close-out visits.

• Support investigators and research teams with protocol planning, evaluation, and participant recruitment.

• Track and report on project progress and the quality of research data.

• Complete regulatory paperwork, data collection, and monitoring plans.

• Achieve and maintain assigned clinical competencies such as phlebotomy, monitoring vital signs, ECG, and point-of-care testing as required.

• Assist during audits and in responding to audit findings.

• Create and sustain research tools, including spreadsheets, questionnaires, and brochures.

• Keep records of study personnel certifications, including licenses, CVs, and CITI records.

• Document the education and training of research personnel.

• Engage in informed consent processes.

• Contribute to the development of research project budgets.

• Perform additional duties as assigned.

⛳️ Requirements

• A High School Diploma or GED is required.

• A minimum of two years of clinical research or healthcare experience is necessary.

• An Associate or bachelor's degree in a healthcare or science field may substitute for some experience requirements.

• Strong organizational, written, and verbal communication skills are essential.

• Must be able to take direction and act appropriately in a high-pressure environment.

• Proficient in word processing, spreadsheets, database and presentation software, as well as internet research.

• Ability to work effectively with a multidisciplinary team.

• Must complete certification in Human Subjects Research within 90 days of hire.

• Capable of performing work in a stationary position for extended periods.

• Ability to operate a computer and other office equipment.

• Skilled in communicating and exchanging accurate information.

• In certain locations, capability to lift up to 25 pounds is required.

• Must adhere to standard precautions using personal protective equipment as necessary.

• Language proficiency is required.

🏝️ Benefits

• Part-time employment opportunities available.

• Annual influenza vaccination or an approved exemption program.

• Drug-free workplace with controlled-substance testing post-offer.

• Equal employment opportunity commitment.