Clinical Research Coordinator

This position will be primarily based at our St. Vincent's East Location; However, training will occur at St. Vincent's Downtown Birmingham

Description of Duties:

• Screens all potential patients for protocol eligibility. Maintains and submits monthly screening logs.

• Presents trial concepts and details to patients and participate in the informed consent process under the direction of the physicians.

• Ensures potential participants fully understand the study during the informed consent process and documents all consent and/or reconsent appropriately.

• Coordinates study patient's scheduling for tests and treatments required by the protocol.

• Documents any changes in the patient's condition, adverse events, concomitant medication use, protocol compliance, and response to the study drug. Reports all findings and any abnormal results or deviations to an R.N. or physician.

• Accurately reports serious adverse events and protocol deviations to the sponsor and/or IRB per protocol and applicable regulatory guidelines.

• Works directly with physicians and other clinic staff to ensure protocol compliance.

• Dispenses oral or IV study drugs using the sponsor-provided portal and transports the study drug to the pharmacy or clinical team for distribution to the patient at the direction of the treating physician. All study drugs are accurately logged in pharmacy accountability and transport logs.

• Ensures accurate and complete data collection, data entry, query resolution, and timely submission of all research data.

• Supports the team by assisting with shared tasks such as pre-screening logs, pharmacy accountability, lab kit management, and equipment tracking.

• Prepares for study visits by reviewing the study protocol, consent form, patient chart, and study-specific checklists.

• Collaborates with team members as needed for eligibility reviews or complex visits requiring additional logistical support (e.g., supply transport or lab processing).

• Supports principal investigators by preparing for monitoring visits, communicating study updates to the research team, assisting with query resolution, and scheduling monitor meetings with the principal investigator.

• Ensures proper documentation of staff delegation and training and collaborates with the regulatory manager to maintain regulatory compliance.

• Provides a safe environment for patients, families, and staff by complying with all federal, state, and professional regulatory standards issued by OSHA and the CDC. Maintains strict patient confidentiality in accordance with HIPAA and conducts all research in compliance with GCP guidelines.

• May occasionally be required to attend after-hours meetings to support investigators with study-required activities.

Additional Skills and Abilities:

• Excellent computer skills,

• Excellent written and oral communication skills,

• Knowledge of medical terminology, anatomy and physiology, clinical medicine, surgery, diagnostic tests, radiology, pathology, pharmacology, hematology and oncology

• Ability to multi-task

• Strong organizational skills

• Ability to work independently

• Strong reading comprehension skills are required for understanding complex study protocols, and regulatory documents.

• Exceptional attention to detail is required

Educational Experience:

High school diploma or GED required,

BS degree preferred, preferably in a science or healthcare related field

Other requirements:

Must have valid driver's license.