Clinical Research Coordinator II, Department of Internal Medicine - Cardiology (Phoenix)

Recruitment and Enrollment:

• Conduct study eligibility screening, recruitment, interviews and evaluation of potential study participants per IRB-approved study protocols.
• Obtain informed consent, collect and maintain participant data.
• Develop study recruitment materials and provide patient education regarding study specific requirements and expectations for participation.
• Coordinate clinical staff education to ensure collaboration on new processes that affect the clinic or hospital operations.

Research Coordination:

• Provide and/or coordinate administration of study treatments, assessments and monitoring of participant health per protocol; ensure participant education concerning protocol responsibilities and maintain ongoing consent.
• Ensure participant and study compliance, i.e., collection of study specimens, completion of protocol required tests and completion of study visits within required study visit windows.
• Complete timely collection, labeling, processing, storage, transport and shipping of biological specimens per IATA requirements if required per protocol.

Data Coordination:

• Perform scientific and clinical data collection, through patient interaction, clinical observation and electronic health record review in local source and Sponsor EDC platforms.
• Maintain detailed records of studies conducted, organize and prepare data for input into a variety of internal and external systems.
• Create and file adequate source documentation, ensure timely data reporting and query response, and perform quality checks.

Troubleshooting:

• Collaborate effectively with other departments to ensure proper progress and completion of study procedures.
• Develop strategies to ensure increased study awareness and subject enrollment.
• Order and maintain supplies required for study kits, track spending in this area, and make day-to-day decisions in support of the study.

Compliance and education:

• Responsible for ensuring compliance with federal regulations for human subject research, University policies, and Sponsor expectations as well as for continuing education relevant to their role.
• Maintaining current human subject research training, attending relevant educational seminars, and professional development in clinical research operations.
• Supports the orientation and training of new research team members, including faculty, residents/fellows, and other staff.

Knowledge, Skills, and Abilities:

• Excellent written and verbal communication skills.
• Ability to multitask with excellent organizational skills.
• Skilled in interacting and working with others; including, peers, patients, management, internal and external stakeholders.
• Ability to work under minimal guidance and use independent judgment to determine best approach.