Clinical Research Coordinator II - California Heart Center

CEDARS-SINAI; Beverly Hills (CA); On-site; USD 75,000 - 105,000; Full time

Job summary

Cedars-Sinai California Heart Center is seeking a Clinical Research Coordinator II to lead assigned studies, coordinating logistics, patient visits, consent processes, data collection, and audit support. You will work with investigators, staff, and sponsors to ensure compliance with FDA/IRB requirements and study protocols.

Ideal candidates have 3 years of clinical research coordination experience, an Associate Degree, and BLS certification.

Qualifications

• Three (3) years of clinical research coordination experience is required.
• Bachelor’s degree preferred; Associate degree required.

Responsibilities

• Establishes and executes logistical aspects of clinical research projects to achieve project objectives, including project planning and resource estimation.
• Coordinates administrative functions: scheduling visits, procedures, labs, and keeping consent forms and source documents up to date.
• Screening and recruitment of potential patients for protocol eligibility; explain non-medical trial concepts and obtain informed consent.
• Accurate and timely data collection, documentation, entry, and reporting; resolve sponsor or regulatory queries.

Skills

MS Office

Cross-functional

Data management

Informed consent

Education

Associate Degree

Bachelor's degree

Job description

Job Description

The mission of the California Heart Center is to integrate quality health care, clinical research, and continuing education to create an environment where advances are fostered for the immediate benefit of patients. The California Heart Center is committed to providing patients with the best medical care and customer service, and to continuously improve the quality of care and service throughout the organization. To learn more, please visit Cedars-Sinai California Heart Center.

Are you ready to be a part of breakthrough research?

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 for the department. This individual will interact 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.

Primary Duties and 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 of patients for research visits, procedures, and labs, and completion and maintenance of consent forms, case report forms, SAE’s, and source documents.
• Responsible for screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and supporting the informed consent process.
• Responsible for 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 designs and implements needed corrective actions.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
• Responsible for timely submission of adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• Identifies quality and performance improvement opportunities and collaborates with staff in the development of 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.
• Provides assistance 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.
• Attend meetings and conferences related to research activities, including research staff meetings.
• Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested; Participate in training and education of new research personnel.

Qualifications

Education:

• An Associate Degree/College Diploma is required. Bachelor's degree preferred.

Licenses and Certifications:

• Basic Life Support (BLS) 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 the compliant execution of assigned tasks in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements.
• Ability to use software applications (MS Office Suite - Excel, Word, Outlook, PowerPoint) and operate technological devices (e.g., computer, laptop, tablet, smartphone, etc.).
• Establishes effective working relationships with cross-functional team(s).
• 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 company with external constituents.