Clinical Research Coordinator II

Tennessee Oncology; Gallatin (TN); On-site; USD 50,000 - 70,000; Full time

Job summary

Tennessee Oncology is seeking a dedicated professional for the management of subjects on clinical trials. The position entails coordinating activities related to clinical trials while ensuring compliance with regulatory requirements and maintaining patient welfare.

The ideal candidate will possess a Bachelor’s Degree, have two years of relevant experience, and demonstrate excellent communication and organizational abilities. This role offers an opportunity to collaborate in a vital healthcare sector.

Qualifications

• Two years of relevant experience required.

Responsibilities

• Manage subjects on clinical trials and coordinate all activities associated with clinical trials.
• Screen potential subjects for clinical trials through a careful review of medical history.
• Maintain informed consent records for each patient during the study.
• Coordinate all patient visits including testing and procedures per sponsor protocol.
• Provide accurate and timely data documentation, entry, and reporting.

Skills

Excellent verbal and written communication skills

Excellent organization and follow-up skills

Ability to handle multiple priorities in a fast-paced environment

Ability to understand complex clinical trials protocols

Ability to function in multi-functional teams

Microsoft Office product knowledge (Word, Excel, PowerPoint)

Bilingual (English/Spanish)

Education

Bachelor's Degree or equivalent combination of education and experience

Job description

Job Description

This position is responsible for the management of subjects on clinical trials and coordinating activities associated with clinical trials.

Essential Functions

• Screens potential subjects for clinical trials through a careful review of the patient’s past medical history and a review of current findings against inclusion and exclusion criteria specific to a trial
• maintains informed consent records of each patient for the duration of a study
• Coordinates all patient visits including testing and procedures as per sponsor protocol
• Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and Tennessee Oncology databases while complying with sponsor protocol requirements, regulations, and department policies
• Assists regulatory staff in the maintenance of regulatory documents in accordance with department policies and regulations
• Liaises with sponsor staff such as study monitors
• Procures, processes, and ships biospecimens per sponsor protocol and regulations
• Protects the rights, safety, and welfare of patients
• Strives to maintain harmonious relationships with clinic team member, administrative staff, patients, their caregivers, and the public
• Reviews newly activated protocols, amendments, notices, suspensions, and terminations
• Responsible for maintaining current knowledge of the Code of Federal Regulations and International Council for Harmonization Guidelines
• Maintains required certification in Good Clinical Practice, Human Subjects Protections, and biological shipping training
• Serves as a liaison to multiple Tennessee Oncology departments, providers, and other team members regarding research protocols and regulatory compliance
• Maintains a professional approach respecting the dignity and confidentiality of patients
• Maintains a good attendance record and reports to work on time
• Maintains a professional attitude and appearance
• Maintain licensure as applicable
• Performs other duties as assigned

Knowledge, Skills & Abilities

• Excellent verbal and written communication skills
• Excellent organization and follow-up skills
• Ability to handle multiple priorities in a fast-paced environment
• Ability to understand complex clinical trials protocols
• Ability to function in multi-functional teams
• Microsoft Office product knowledge (Word, Excel, PowerPoint, etc.)
• Bilingual (English/Spanish) a plus

Education & Experience

• Bachelor’s Degree or equivalent combination of education and experience required
• Two years of relevant experience required