Clinical Research Coordinator I

Position Summary

The Clinical Research Coordinator manages clinical trials conducted through the Clinical Protocol & Data Management Office. This position reports directly to the Clinical Research Manager of the specific disease site this incumbent is assigned to. Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

Responsibilities

The Clinical Research Coordinator manages clinical trials (including some regulatory and budget requirements) and assists in the coordination of tests/visits for patients, working with the study team to maximize work efficiency to gather all required data and relevant clinical information.

Responsibilities include, but are not limited to:

GENERAL STUDY MANAGEMENT

• Reviewing research protocols.
• Assisting Principal Investigators in study start up and submitting studies to appropriate offices.
• Interacting with the regulatory team to maintain regulatory documentation and administrative files for each protocol
• Under the supervision of the clinical research manager, the coordinator maintains procedures necessary for timely and complete data management, and complies with required supervision tools such as work logs and regular meetings. The coordinator will also comply with necessary regulatory responsibilities as needed.

PATIENT MANAGEMENT

• Coordinates study enrollment, protocol treatment, and follow-up care for patients participating in clinical trials in conjunction with the clinical research nurse, research pharmacy, treatment center and other study staff.
• Working with the research nurse, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials.
• Communicating with various departments, physicians, labs, outside hospitals, and all members of the clinical team to ensure accuracy, timely retrieval of data, and confirm the appropriateness and timeliness of tests.
• Collecting follow-up data on patients' post-treatment as required by the protocol and submit monthly reports to the clinical protocol office, tracking patient enrollment and accounts/payments for sponsored protocols.
• Completes timely research billing review
• Maintains and updates sponsor-related, university and department databases/logs

DATA MANAGEMENT

• Handling data management requirements for each patient enrolled.
• Abstracts, assembles, and organizes clinical research data.

OTHER

• Coordinator performs other related duties and participates in special projects as assigned.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor’s degree or equivalent in education and/or experience.

Preferred Qualifications

• Two years of related experience or equivalent in education.
• Excellent interpersonal and organizational skills.
• Computer Skills: proficiency with MS Word programs and familiarity with Mac and PC platforms.
• Experience in clinical research setting with knowledge of HIPAA and GCP.