Clinical Research Coordinator II - California Heart Center

About the Organization

The California Heart Center is dedicated to integrating quality healthcare, clinical research, and continuing education to foster advances for the immediate benefit of patients. The center is committed to providing exceptional medical care and customer service while continuously improving the quality of care and service throughout the organization.

About the Role

The Clinical Research Coordinator II serves as the lead coordinator on an assigned portfolio of research studies, functioning independently to establish and coordinate logistics and processes for the conduct of research within the department. This role involves interaction with principal investigators, subjects, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and Sponsor representatives to successfully implement research protocols in compliance with all applicable regulatory requirements.

Responsibilities

• Establishes and executes logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety.
• Coordinates administrative functions of research studies, including scheduling patients for research visits, procedures, and labs, and completion and maintenance of consent forms, case report forms, SAEs, and source documents.
• Responsible for screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to patients, and supporting the informed consent process.
• Ensures accurate and timely data collection, documentation, entry, and reporting, including resolution of queries from sponsors or regulatory entities.
• Coordinates institutional, pharmaceutical, and internal audits, including facilitating third-party study monitoring and designing and implementing needed corrective actions.
• Compiles and reports on each study, including information related to protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings.
• Submits adverse events, serious adverse events, protocol deviations, and Safety Letters in a timely manner in accordance with local and federal guidelines.
• Identifies quality and performance improvement opportunities and collaborates with staff in developing action plans to improve quality.
• Plans and coordinates strategies for increasing research participant enrollment and/or improving clinical research efficiency as needed.
• Provides technical support for the preparation of grant proposals, publications, presentations, and special projects.
• Assists with research project budget development, including identifying and classifying routine care vs. research-related care, and provides assistance with research participant research billing and reconciliation.
• Attends meetings and conferences related to research activities, including research staff meetings.
• Participates in planning, workshops, evaluation meetings, seminars, educational or administrative meetings as necessary or requested; participates in training and education of new research personnel.

Qualifications

An Associate Degree or College Diploma is required. A Bachelor's degree is preferred.

Certifications

• Basic Life Support (BLS) certification is required.
• Certification in Clinical Research (SoCRA or ACRP certification), Phlebotomy Certification (CA), and Certification as a Registered Medical Assistant are preferred.

Experience and Skills

• Three (3) years of clinical research coordination or related experience is required.
• Maintains comprehensive knowledge of assigned research protocols to coordinate compliant execution of tasks in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements.
• Proficient in using software applications (MS Office Suite - Excel, Word, Outlook, PowerPoint) and operating technological devices (e.g., computer, laptop, tablet, smartphone).
• Establishes effective working relationships with cross-functional teams.
• Collaborates to solve problems and make decisions to achieve desired outcomes.
• Cultivates and maintains strong customer relationships and rapport with stakeholders and/or client groups.
• Identifies and responds appropriately to internal and external customer needs utilizing available resources.
• Represents the organization professionally with external constituents.