Research Study Coordinator

OneOncology • Huntsville, AL

125d

About The Position

A Research Study Coordinator is responsible for the day-to-day planning, execution, and monitoring of complex oncology clinical research protocols. This is done in a manner to assure trial integrity and patient safety.

Requirements

• Must have demonstrated proficiency with Microsoft 365.
• Must have working knowledge of computer data management systems.
• Must have interest in clinical research.
• Must be detail-oriented with strong critical-thinking skills.
• Must have excellent communication skills, both oral and written.
• Must work well independently and with diverse teams.
• Must have the ability to handle multiple priorities in a fast-paced environment.
• Must have the ability to understand complex clinical trial protocols.

Nice To Haves

• BSN RN preferred.
• GCP certification preferred.
• OCN certification preferred.
• At least (1) year research experience is preferred.

Responsibilities

• Consents and acknowledges personal data are provided to study sponsors, CROs, auditors, and authorities in accordance with reporting guidelines for clinical trials, ICH, and the Code of Federal Regulations.
• Coordinates with research team, other CCI departments, trial sponsors, and patients to ensure protocol adherence.
• Manages data collection, source documentation, case report forms, and adverse event reporting.
• Performs patient recruitment, screening, enrollment, and follow-up in accordance with the trial's protocol.
• Maintains GCP (Good Clinical Practice) and IATA certifications as required to uphold FDA standards regarding clinical trials.
• Responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and dispensation to research participants.
• Coordinate and attend trial initiation visits and attend all protocol required meetings and trainings.
• Coordinate patient care, safety, trial data collection, and quality with treating providers, PI, research staff, necessary CCI departments, and external providers.
• Perform consent process defined by ICH GCPs and CCI Research SOPs.
• Directly interact with patients for clinical trial schedules, treatments, follow-up and study information.
• Pre-screening of patients using available electronic platforms for possible inclusion in clinical trials.
• Report SAEs according to protocol and SOPs.
• Maintain patient privacy and confidentiality in accordance with applicable law.
• Maintain study confidentiality.
• Provide payment milestones per CTA in a timely manner.
• Comply with CCI and departmental policies and procedures.
• Duties as assigned for trials according to trial delegation logs (DOAs) for clinical trials at CCI.

What This Job Offers

• Job Type: Full-time
• Education Level: Bachelor's degree