Clinical Research Coordinator

Job Summary

The Clinical Research Coordinator (CRC) functions as the lead coordinator for multiple studies, ensuring that all protocol requirements are met for each enrolled patient. The coordinator is responsible for screening and recruitment of eligible patients, patient education and follow-up, preparation of case report forms, accurate protocol documentation, and drug accountability. The CRC provides professional care through practice, education, and research. The CRC collects and assesses data required by the individual protocol and reflective of the patient's status and appropriately interpret information relative to the patient's age-specific needs.
Essential Job Functions
Develops source documents for assigned studies. Manages data collection and ensures all adverse events (AEs) are identified and reported appropriately. Develops informed consent for subjects.

Performs electrocardiograms (ECGs), collects blood specimens and processes blood, fecal, urine and other specimens for local analysis or shipment to reference laboratories.

Collects, completes and enters all documentation. Identifies possible AE, side effects, or significant changes in patient's condition and communicates pertinent information to appropriate caregivers.

Provides appropriate patient and family education. Discusses informed consent with patients and verifies the informed consent documentation.

Prepares and submits regulatory documents for submission to the Institutional Review Board (IRB).

Collaborates with the Principal Investigators and other health care professionals in planning approaches to carrying out the requirements of the research study protocol and adherence to research Good Clinical Practice (GPC).

Communicates reports and instructs staff on the purpose, background, and methodology of research study requirements. Discusses and explains the research study protocols. Conducts education of physician and nursing staff on specifics of the protocol, study design and investigational therapeutic agents, procedures and/or techniques specific to the assigned study.

Ensure scientific integrity of data and protect the rights, safety and well-being of patients enrolled in clinical trials.

Performs other duties as assigned or needed to meet the needs of the department/organization.

• Demonstrates understanding and follows infection control policies and procedures according to standard operating procedure.
• Maintains requirements for age specific competencies for the position and demonstrates the knowledge or principles of growth and developments and the skills necessary to provide patient/customer care/services.
• Demonstrates knowledge and understanding of and compliance with:
  • All pertinent safety, health and environmental policies, procedures and guidelines.
  • Working safely, without causing harm or risk to self, others or property.
  • The work environment safety procedures and prompt reporting of unsafe practices, procedures, accidents, injuries or other safety violations to the Leader.
  • The use of all safety equipment and personal protective equipment.

License, Certification & Registration
Title

Credentialing Body

Timeframe When Needed

Verified By

Clinical Research Coordinator Certification

Assocaition for Clinical Research Professionals

Preferred

Employee Provides HR a Copy

Clinical Research Coordinator Certification

Society of Clinical Research Associates

Preferred

Employee Provides HR a Copy

Basic Life Support (BLS)

AHC or ARC CPR for Prof. Rescue

Within 3 Months of Start Date

Employee Provides HR a Copy

Experience

Required/Preferred

A minimum of 2 years of related experience

Required
Knowledge & Skills
Title

Required/Preferred

Demonstrates the ability to effectively communicate both verbally and in written format.

Required

Demonstrates the ability to be a team player, able to handle conflict and adapt to change.

Required

Demonstrates strong interpersonal communication and customer service skills.

Required

Demonstrates the ability to use various software programs, including EMR software.

Required