Clinical Research Coordinator I

The Clinical Research Coordinator I will oversee multiple clinical trials, serving as a point person for patients, their family members, and the clinical study team. The position consists of working with various departments across the hospital, including forging new partnerships with departments to ensure completion of trial-related activities. The clinical research coordinator I will direct participants and study team members to adhere to the study protocol and rules and regulations as governed by regulatory bodies including Institutional Review Boards and the FDA.

Job Responsibilities

- Directing seamless flow of daily trial-related activities, recruitment and clinical assessments of the study subjects

- Directing strict adherence to the study protocols, as well as sponsor, FDA and other regulatory authority requirements.

- Developing workflows for clinical trial, including reminders/updates to the clinical team

- Coordinating team members to complete both clinical and non-clinical assessments per protocol. This includes developing workflow for patient care such as assigning secretaries to schedule patients, developing workflow with ancillary departments (such as radiology, advanced imaging, pathology, pharmacy), and assigning appropriate clinical team members such as doctors to complete clinical tasks such as reviewing adverse events versus assigning non-clinical team members to complete non clinical tasks such as administering questionnaires to a patient.

- Executing IRB submissions (event reporting, study status change etc.)

- Executing patient billing in multiple databases including the patient’s electronic medical record.

- Developing action plans for ensuring all study tasks are completed as required per the protocol and developing subsequent corrective action plans if any errors are made.

The Clinical Research Coordinator I will be trained to be highly specialized in clinical trials assigned to them, and is expected to be able to manage clinical trial projects independently after sufficient training is completed.

Requirements

Bachelor's degree Required

CITI Good Clinical Practice Certification, CITI Research with Biomedical Drugs and Devices Certification, CITI Dangerous Goods and Biospecimen Handling Certification
Experience in clinical research, clinical trials, and/or any medical related profession highly Preferred