Clinical Research Coord I - Innovate and Research

Kettering Health • Kettering, OH

1d • Onsite

About The Position

The Clinical Research Coordinator I (CRC I) is a professional with clinical research expertise preferred. Under the supervision of the Manager, Innovation, Research & Grants at KHN, the CRC I will collaborate with physicians and other healthcare providers, scientists, administration, the Institutional Review Board, Sponsors, and the Food and Drug Administration (FDA). The CRC I is responsible for assisting the Investigator in accomplishing successful research trials. The CRC I is expected to adhere to Good Clinical Practice (GCP) guidelines as set forth by the Federal regulations. The CRC I will screen, enroll, and follow study subjects, ensuring protocol compliance and close monitoring of the subjects participating in the research study. The CRC I is responsible for all data reporting via source documents including adverse event reporting. Maintenance of complete regulatory files will be coordinated with the Regulatory Documentation Specialist (RDS). Depending on the requirements of a specific protocol, other duties may be assigned based upon the CRC’s qualification, training, experience and licensure, when applicable. The CRC I will adhere to policies of the Innovation, Research & Grants related to compliance of Federal regulatory issues, education, training, and GCP. This individual must be able to work independently under limited supervision, while maintaining excellent communication between the principal investigator(s) and all staff involved in any aspect of approved research projects.

Requirements

• Bachelor's Degree required
• Must be able to read and write English.
• Must be able to follow oral and written directions.
• Must be able to collaborate in work projects.
• Possess the ability to manage multiple project priorities.
• Must be able to work independently.
• Must be able to collect data accurately.
• Must be able to complete tasks in a timely manner.
• CPR basic life support certification is required.

Nice To Haves

• Clinical research expertise preferred.
• Degree in Science Medical Field.
• 1-2 years of Clinical Research experience (patient oriented).
• Recent graduates are accepted if they have schooling involved in field.

Responsibilities

• Screen, enroll, and follow study subjects.
• Ensure protocol compliance and close monitoring of subjects.
• Responsible for all data reporting via source documents including adverse event reporting.
• Coordinate maintenance of complete regulatory files.
• Assist the Investigator in accomplishing successful research trials.
• Adhere to Good Clinical Practice (GCP) guidelines.
• Adhere to policies of the Innovation, Research & Grants related to compliance of Federal regulatory issues, education, training, and GCP.
• Work independently under limited supervision.
• Maintain excellent communication between the principal investigator(s) and all staff involved in any aspect of approved research projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level