Clinical Research Coordinator-RN II

Iconma

Newport Beach, CA

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JOB DETAILS

SKILLS

Adverse Events, Analysis Skills, Aviation Industry, Basic Life Support (BLS), Best Practices, Budget Management, Budgeting, Business Skills, Case Report Form (CRF), Clinical Assessment, Clinical Data, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Clinical Trial Management, Communication Skills, Cost Analysis, Cost Control, Customer Experience, Customer Relations, Customer Satisfaction, Customer Support/Service, Data Analysis, Data Cleaning, Data Collection, Data Entry, Data Quality, Detail Oriented, Diversity, Documentation, Drug Development, English Language, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, GCP (Good Clinical Practices), Government Funding, Health Plan, Healthcare, High School Diploma, ICH Regulations, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Informed Consent, Interpersonal Skills, Maintain Compliance, Medical Records, Mentoring, Microsoft PowerPoint, Microsoft Word, National Institutes of Health (NIH), Needs Assessment, Nursing, Nursing Credentials, Nursing Management, Operational Support, Organizational Skills, Patient Confidentiality, Presentation/Verbal Skills, Problem Solving Skills, Project/Program Management, Protocol Analysis, Quality Management, Record Keeping, Registered Nurse (RN), Regulations, Regulatory Requirements, Sample/Specimen Processing, Site Initiation, Society of Clinical Research Associates (SoCRA), Specimen Collection, Specimens/Samples, Team Building, Team Player, Time Management, Writing Skills

LOCATION

Newport Beach, CA

POSTED

Today

Our Client, a Healthcare company, is looking for a Clinical Research Coordinator-RN II for their Newport Beach, CA location.

Responsibilities:

The Clinical Research Coordinator-Registered Nurse II (CRC RN-II) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors.
The position is responsible for managing complex clinical research trials including drug, device, and biologic studies across Phase I, II, III, and IV clinical trials, government-funded research, and investigator-initiated studies while ensuring compliance with Good Clinical Practice standards, human subject protection regulations, and FDA guidelines.
Manages complex clinical research trials including industry-sponsored, government-funded, and investigator-initiated studies.
Maintains compliance with Good Clinical Practices, FDA regulations, and human subject protection standards.
Provides overall study management, coordination, and operational support for assigned research trials.
Performs protocol review and preparation activities prior to study initiation.
Administers and manages the informed consent process in accordance with regulatory requirements.
Conducts subject recruitment, screening, and eligibility assessments based on inclusion and exclusion criteria.
Collects, processes, and documents laboratory samples in compliance with International Air Transport Association standards.
Ensures completion of all protocol-required clinical assessments and procedures.
Accurately collects, records, and enters study data into clinical research databases while maintaining data integrity and quality.
Completes case report forms and addresses data queries in a timely manner.
Monitors and reports adverse events according to protocol and regulatory requirements.
Maintains regulatory binders and study documentation in accordance with sponsor and regulatory standards.
Develops study flow sheets and prepares study source documentation.
Hosts and participates in study team meetings and site initiation visits.
Assists with cost analysis, study budget preparation, and tracking and distribution of study funds.
Supports the growth and strategic vision of the Client Institute for Research and Education.
Assists with training and mentoring other Clinical Research Coordinators as needed.
Promotes team building and fosters a positive and respectful work environment.
Performs other duties as assigned.
The CRC RN-II 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. Maintains knowledge of best practice and standards for Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research. The CRC RN-II provides overall study management, support, and coordination of clinical research trials. The CRC RN-II 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 and maintenance of regulatory binders. Responsible for development of study flow sheets, prepare study source documentation, gathers study data, and assess subject for study eligibility (inclusion/exclusion). Collecting and processing of lab samples per IATA standards and ensuring protocol required assessments are completed. The CRC RN-II will record protocol specific assessments and treatments, reviews and enters clean data into study database while maintaining data quality, and addresses queries in a timely manner. Hosts study team meetings, attend site initiation visits (SIVs) and performs other duties as assigned. The CRC-RN assists in developing a detailed cost analysis, study budget preparation, and tracking/distribution of study funds. This position works to support growth and vision of the Client Institute for Research and Education.
The CRC RN-II may also assist with training other CRCs within the team. Encourages team building activities and fosters growth in a positive respectful environment.

Requirements:

Excellent analytical and problem-solving skills.
Follows policies set by the organization and department.
Two (2) or more years of experience performing clinical research duties or equivalent experience and training.
Knowledge of Good Clinical Practices, protection of human subjects, and FDA regulatory guidelines.
Excellent verbal and written communication skills.
Strong organizational skills with close attention to detail.
Excellent interpersonal skills to work effectively within a diverse team environment.
Strong analytical and problem-solving skills.
Proficiency in Microsoft Word, PowerPoint, and Windows-based applications.
Ability to work effectively in a fast-paced, team-based environment.
Project management and coordination skills with the ability to prioritize tasks and meet multiple deadlines.
Ability to establish and maintain cooperative working relationships with patients, physicians, and coworkers.
Ability to behave professionally in all work settings and promote team-building behaviors.
Ability to follow organizational and departmental policies and procedures.
Working knowledge of FDA, NIH, and OHRP regulatory requirements.
Working knowledge of ICH Good Clinical Practice guidelines.
Understanding of clinical trial methodologies.
Experience filing Institutional Review Board documentation.
Ability to abstract data from medical records and transfer information into data collection forms or electronic databases.
Bachelor of Science in Nursing (BSN) Degree or higher.
Current licensure in good standing as a Registered Nurse in the State of California.
Basic Life Support (BLS) Certification.
Current ACRP Certification.

SoCRA Certification.
Nursing Specialty Certification.
International Air Transport Association (IATA) Certification.
English( Speak, Read, Write )
Protocol review
Clinical research
Good clinical practices
Fda regulations
Human subject protection
Informed consent processs
Ubject recruitment
Screening
Eligibility assessment
Laboratory sample collection
International air transport association standards
Clinical assessments
Data collection
Data entry
Data integrity
Case report forms
Adverse event monitoring
Regulatory binders
Study documentation
Study flow sheets
Source documentation
Study team meetings
Site initiation visits
Cost analysis
Study budget preparation
Study fund tracking
Training and mentoring
Team building
Analytical skills
Problem solving
Verbal communication
Written communication
Presentation skills
Organizational skills
Attention to detail
Interpersonal skills
Project management
Task prioritization
Microsoft word
Powerpoint
Completed High School (Diploma or GED)
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. This clinical positions includes clinical procedures required by department and unit, as demonstrated by unit-based competency testing.
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.
Organization Behavioral Competencies
Trust & Accountability
Demonstrates honest and ethical behavior. Takes responsibility for both words and actions. Acts with integrity. Maintains patient confidentiality.
Business Acumen: 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.
Customer Satisfaction: Delivers superior customer service consistent with the Client 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 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.
Innovation: 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.
2+ years of experience and demonstrates skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
Bachelor of Science in Nursing (BSN) Degree or higher
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.
Reports To: Nurse Supervisor, Supervisor, Manager or Director of Clinical Research

Why Should You Apply?

Health Benefits
Referral Program
Excellent growth and advancement opportunities

ICONMA is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to any status protected by applicable law.

About the Company

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
Founded in 2000
2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Management Consulting Services

EMPLOYEE BENEFITS

401K, Employee Referral Program, Life Insurance

FOUNDED

2000

WEBSITE

https://www.iconma.com/

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