Apply on Employer Site

The Christ Hospital Health Network · 2 months ago

Clinical Research Coordinator II - MOB Lindner Research HV - Full Time - Days

Cincinnati, OH

Full-time

Onsite

Entry, Mid Level

2+ years exp

The Christ Hospital Health Network is seeking a Clinical Research Coordinator II to support the Principal Investigator and the Lindner Center for Research and Education. The role involves coordinating daily clinical trial activities, ensuring compliance, and maintaining data integrity throughout the study process.

Health CareHospitalMedical

Responsibilities

Maintain awareness of status of all active studies

Arrange for facilities and supplies

Ensure participant and study compliance, i.e. collection of specimens or data

Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies

Register, schedule, and conduct clinical study visit in conjunction with other(s), such as PI, and/or other clinical services

Ensure accurate and timely preparation, submission and maintenance of all regulatory submissions (proposed new studies, annual review, amendments, adverse events)

Oversee the review, correspondence and approval of human research protocols with regulatory authorities, including study close out

Apply legal, regulatory and policy parameters to promote ethical practices in research involving human participants and to ensure compliance to those regulations

Determine best method(s) to identify potential participants for research protocols (advertisements, chart review, monitoring of clinic schedules, etc.)

Create and maintain a detailed tracking system for participants enrolled in study

Track progress and report to appropriate source and PI

Conduct pre-consent screening to determine eligibility. Review consent form with participant and perform the informed consent process

Oversee creation of case report forms (CRFs) in consultation with other team members, using existing study data information to promote efficient data collection and data entry

Complete CRFs and source documentation in compliance with all applicable guidelines for human research

Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice

Review documentation from sources to ensure accuracy

Enter data into various auditable databases or electronic data-capture systems and/or oversee data entry and validation

Assist in data analysis and maintain record keeping and data storage

Compose, document, organize, and maintain all correspondence. Oversee and follow through on questions and issues that arise during study conduct

Serve as liaison to internal departments, clinical teams, regulatory agencies and participant(s)

Develop a rapport with participating physicians, staff and study participants

Qualification

Clinical research experienceRegulatory complianceData managementClinical research certificationsSoftware skillsDatabase skillsOrganizational skillsCommunication skills

Required

Bachelor's degree required

2-4 years clinical research experience with conducting clinical trials/studies

Photocopier, fax equipment, software and database skills, all medical equipment appropriate to research and strong organizational and communication skills