Clinical Research Coordinator

Neurology Center of North Orange Co; California (MO); Vor Ort; USD 55.000 - 75.000; Vollzeit

Zusammenfassung

Neurology Center of North Orange Co in Fullerton, CA, seeks a Clinical Research Coordinator to manage all aspects of clinical trials. You will coordinate visits, collect data, and ensure compliance with IRB, HIPAA, and sponsor requirements.

The role emphasizes organization, communication, and patient-focused service; requires at least six months in clinical research, with preference for more than a year and phlebotomy experience.

Qualifikationen

• Must have a minimum of 6 months of experience in clinical research.
• Some college experience required; a bachelor’s degree is preferred but not required.
• Preference for candidates with more than 12 months experience and phlebotomy experience.

Aufgaben

• Communicates with principal and sub-investigators regarding protocol changes, subject updates, and recruitment strategies.
• Maintains constant availability to subjects for updates, questions, and emergencies.
• Performs face-to-face and telephone protocol-specified research visits.
• Maintains an up to date EDC system, and answers queries in a timely manner.
• Implements IRB approved protocol changes to visits and source documentation.
• Ensures accurate and secure study information, meeting the guideline of ALCOA for data integrity.
• Obtains laboratory samples, ECGs, and vitals.
• Obtains, reviews, and records medical history for the subject during the duration of the trial.
• Communicates with subjects and/or caregiver regarding medication changes, adverse events, scheduling visits, and study drug compliance.
• Documents adverse events as reported by the study participant, and meets mandatory reporting guidelines per sponsor and/or IRB
• Performs initial and revised informed consent process with subject and/or caregiver.
• Administers scales, diagnostic testing, and other study assessments.
• Follows and observes HIPAA guidelines for the protection of PHI for research subjects.

Kenntnisse

Communication skills

Organization

Confidentiality

Customer service

Phlebotomy

Ausbildung

Some college experience

Bachelor’s degree preferred

Jobbeschreibung

Job Description

Position Summary:

The Clinical Research Coordinator undertakes the performance of clinical trials. The individual seeking this position will be responsible for all aspects of completion of the research study. Ideal candidate will possess outstanding organization, communication skills, and an ability to adjust and interact with various types of people. Must be a team player, maintain confidentiality, and be comfortable working in the medical field. Candidate will demonstrate customer service that is compassionate, courteous, friendly, non-judgmental, and demonstrate a respect for privacy.

Location: Fullerton, CA

Work Schedule: Monday through Friday: 8:00 am - 5:00 pm, additional hours as necessary.

Education: Some college experience required. Bachelor’s degree preferred but not required.

Experience: Must have a minimum of 6 months of experience in clinical research.

Preference given for individuals who have more than 12 months experience in the above field. Preference given for individuals with experience in phlebotomy.

CRC duties include, but not limited to:

• Communicates with principal and sub-investigators regarding protocol changes, subject updates, and recruitment strategies.
• Maintains constant availability to subjects for updates, questions, and emergencies.
• Performs face-to-face and telephone protocol-specified research visits.
• Maintains an up to date EDC system, and answers queries in a timely manner.
• Implements IRB approved protocol changes to visits and source documentation.
• Ensures accurate and secure study information, meeting the guideline of ALCOA for data integrity.
• Obtains laboratory samples, ECGs, and vitals.
• Obtains, reviews, and records medical history for the subject during the duration of the trial.
• Communicates with subjects and/or caregiver regarding medication changes, adverse events, scheduling visits, and study drug compliance.
• Documents adverse events as reported by the study participant, and meets mandatory reporting guidelines per sponsor and/or IRB
• Performs initial and revised informed consent process with subject and/or caregiver.
• Administers scales, diagnostic testing, and other study assessments.
• Follows and observes HIPAA guidelines for the protection of PHI for research subjects.

Additional CRC Duties:

• Ensures adequate temperature regulation occurs for investigational products, laboratory supplies, and other temperature-specific materials.
• Maintains inventory and accountability of investigational product.
• Administration of study medication and/or application of study devices, when appropriate
• Instructs subjects on the proper administration of investigational product and/or accompanying devices or diaries.
• Contacts potential subjects and administers IRB approved telephone screening questionnaire.
• Informs physicians and other healthcare professionals of available research opportunities.

Job Type: Full-time

Job Location: Fullerton CA

Required education:

• Some college experience, preference given for applicants with a college degree

Required experience:

• Must have a minimum of 6 months of experience in clinical research

Company Description

Neurology medical practice.