Research Study Coordinator

Astera Cancer Care; Huntsville (AL); On-site; USD 55,000 - 85,000; Full time

Job summary

Astera Cancer Care in Huntsville, AL seeks a Research Study Coordinator to manage day-to-day planning, execution, and monitoring of complex oncology protocols, ensuring trial integrity and patient safety.

The role requires coordination with sponsors, CROs, and trial staff, data capture, IP handling, consent, SAE reporting, and adherence to GCP/IATA standards. RN with oncology experience preferred; travel up to 25% may be needed.

Qualifications

• RN in Alabama in good standing and oncology experience preferred.
• Detail-oriented with strong written and verbal communication.
• Experience with EMR systems and data management is desirable.

Responsibilities

• Coordinate day-to-day planning, execution, and monitoring of oncology clinical trials.
• Ensure protocol adherence, patient safety, and trial integrity.
• Manage data collection, source docs, case report forms, and SAEs.
• Perform patient recruitment, screening, enrollment, and follow-up per protocol.
• Maintain GCP and IATA certifications; handle Investigational Product logistics.

Skills

Attention to detail

Excellent communication

Independent work

Multitasking

Critical-thinking

Education

Registered Nurse (RN) in Alabama

BSN preferred

GCP certification preferred

OCN certification preferred

EMR experience

Tools

Microsoft 365

MS Office Suite

Job description

Why Join Us?

We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

Job Description:

Job Purpose 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.

Essential Job Functions

• 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.
• Must have strong computer skills and working knowledge of MS Office Suite, cloud-based EMR systems, data capture systems, medical terminology, and oncology terminology.
• Must be willing to learn and adapt to changing practices, systems and requirements for efficient clinical management and clinical trial execution
• 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.

Qualifications

• 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

Education/Experience

• Must have registered nurse RN in good standing with the State of Alabama.
• Must have at least (1) year infusion experience.
• Must have at least (1) year oncology experience, preferred 2 years of oncology experience.
• Must have at least (1) year EMR experience.
• BSN RN preferred.
• GCP certification preferred.
• OCN certification preferred.
• At least (1) year research experience is preferred.

Working Conditions

This position works in the research department of a busy outpatient medical facility. Direct patient care is required.

Physical Requirements

• Must be able to safely move patients.
• Must be able to lift and carry 30 pounds.
• Must be comfortable standing and walking for long periods of time.
• Must be willing to travel domestically up to 25% of the time.
• Must have reliable transportation.

Direct Reports

This position is not a supervisory position. We are looking for compassionate, adaptable individuals who demonstrate the desire to lead and work together to best treat the patients we serve.