Summary

Primary responsibilities include patient enrollment, screening, monitoring of research participants, and reporting to the clinical research sponsor. The Research Coordinator II will be responsible for ensuring accurate data collection, documentation, organization among a variety of TCH/BCM departments and safety of study volunteers. 

This position will be working directly with physicians and investigators to follow up on study patients. Must have a working knowledge of FDA Good Clinical Practices, and the ability to read, analyze, and interpret information.

Applicants must be willing to work in a fast pace setting, comfortable working in a team environment, and possess excellent communication skills. 

Open to candidates eligible for TN visa status.

Job Duties

Screening & Enrollment: 20% of Duties

• Interviews, screens and recruits patients for enrollment in studies. 
• Explains process and procedures to educate participants regarding the research study. 
• Performs the subject consent process of patients after verifying eligibility based on comprehensive inclusion and exclusion criteria outlined in the protocol.

Subject Visits: 30% of Duties 

• Conducts subject research study education as required within the scope of practice. 
• Discusses study protocols with patients and verifies the informed consent documentation.
• Schedules and coordinates research participants for tests and procedures such as laboratory tests, surveys completion, and other studies specific for the research protocol. Explains processes and procedures to educate the participants regarding the respective research study.
• Sample collection, processing, and coordinating sample shipments.
• Maintain study regulatory documentation.

Data Management: 40% of Duties

• Collect patient information; process documents and enroll patients into study specific database/registries.
• Collect additional data from Electronic Medical Records (EPIC) and maintain study specific databases/registries .
• Conduct periodic review of data for accuracy.

Other: 10% of duties

• Performs other job-related duties as assigned.
• Attends regular meetings with PIs, and study team for update reports and process improvement.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• One year of relevant experience.

Preferred Qualifications

• Two years of research coordination experience strongly preferred.
• Ability to understand the complexities of clinical trials and research protocols, including issues related to informed consent, access to data, and conflict of interest.