Clinical Research Coordinator III
16105 Sand Canyon Avenue Irvine, CA 92618 US
**salary will be commensurate with experience**
Reporting to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations, the Clinical Research Coordinator III (CRC-III) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors.
The CRC-III is responsible for managing complex clinical research trials including drug/device/biologic studies that may involve industry-sponsored Phase I, II, III and IV clinical trials, government funded clinical research and investigator initiated clinical research.
The CRC-III provides overall study management, support, and coordination for FDA regulated research industry-sponsored, government funded, and/or investigator initiated clinical research trials. The CRC-III is involved in all aspects of research studies from protocol review, preparation and administration of the informed consent, subject recruitment, accurate data collection and completion of case report forms (CRFs), adverse event reporting, and scheduled subject follow-up.
The CRC-III is involved in all aspects of the clinical research process included, but no limited to protocol review, preparation and administration of the informed consent, development of study treatment plans, completion of study related visit forms, and ensuring protocol required assessments are completed.
He/she ensures accurate completion of case report forms (CRFs), adverse event/serious adverse event (SAE) reporting, scheduled subject follow-up, and maintenance of regulatory binders.
The CRC-III may also assist with training other CRC’s within the team. The CRC-III will also work with Clinical Research Leadership and Institute leadership to develop and optimize processes between collaborating partnerships and operationalize and maintain operations for early therapeutics and other immunotherapy and other trials.
Responsible for development of study flow sheets, prepare study source documentation, gather study data, and assess subject for study eligibility (inclusion/exclusion). In addition, the CRC-III will record protocol specific assessments and treatments, ensure collection and shipment of samples, collect, enters and clean data into study database while maintaining data quality. He/she will host study team meetings, attend site initiation visits (SIVs) and perform other duties as assigned. Performs other duties as assigned.
Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research.
Diversity - Ability to work with a diverse group of people in a manner that enables them to reach their full potential, in pursuit of organizational objectives, without anyone being advantaged or disadvantaged by irrelevant considerations.
Equipment Knowledge – Knowledge of equipment, tools, technology and other devices in work area and the ability to use them to the extent required for the job. For clinical position, this includes equipment and devices pertinent to treatment, procedures and practice.
Job Knowledge - The knowledge and understanding of concepts and procedures needed to be successful in the job. For clinical positions, this includes clinical procedures required by department and unit, as demonstrated by unit-based competency testing. (formerly Process Knowledge)
Interpersonal Skills - Listens to and understands what others are saying. Establishes effective working relationships with others, contributing to a climate of mutual respect and cooperation. Uses vocabulary and grammar appropriate to the situation. Demonstrates sensitivity and tact, understanding own effect on the motivation, attitudes and actions of others. Makes favorable first impressions.
Oral/Written Communication - Ability to speak and write effectively, demonstrates fundamental command of language, communicates well using all mediums.
Travel – Position may require local travel between various Organization locations.
Organization Behavioral Competencies
TRUST & ACCOUNTABILITY
Demonstrates honest and ethical behavior. Takes responsibility for both words and actions. Acts with integrity. Maintains patient confidentiality.
Uses resources, equipment and finances appropriately. Demonstrates the functional and technical skills to do the job effectively. Willing and actively shares his/her knowledge with others. Accepts changes and adapts to new situations and responsibilities.
Delivers superior customer service consistent with the Experience. Displays a professional image. Demonstrates tact, diplomacy and understanding when dealing with difficult situations. Listens and asks questions to understand patient and customer needs. Builds relationships with internal customers and employees. Admits mistakes and takes service recovery to steps to ensure any issues or problems are quickly addressed. Ensures that all information and services provided are safe, accurate, and available in a timely manner and meet regulatory requirements.
Brings forth creative ideas (one’s own or others) to address patient, physician, customer, and community needs. Looks for creative or new ways to improve efficiencies and reduce costs. Adopts new processes, techniques and methods. Stays current with technologies and advances in his/her area, department and/or field.
• High School Diploma with 4-6 years of Clinical Research Coordinator experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
• Attention to details.
• Proficiency with Microsoft Word, PowerPoint, and Windows.
• Excellent analytical and problem-solving skills.
• Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.
• Ability to establish cooperative working relationships with patients, co-workers, & physicians.
• Bachelor’s Degree or Equivalent
• Current ACRP or SoCRA Certification.
• Medical terminology required. Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines.
• Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.
• Ability to abstract data from medical records and transfer it to data collection forms or directly into databases.
• International Air Transport Association (IATA) Certification
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.