Clnical Research Coordinator

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

Title and Description

Duties

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

Development

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.

AE

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.

Education

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

IRB

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

Planning

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).

Requirements

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.

Integrity

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

Other Duties

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

Safety & Compliance

• 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.

Behavior Standards

• Integrity: We will always do the right thing even when no one is watching.
• Acknowledge: We will create a welcoming, healing environment.
• Meaningful: We will provide an exceptional patient experience.
• Accountable: We will accept responsibility for our actions and behaviors.
• Listen: We will listen and seek to understand.
• Team: We will work together to deliver world-class care.
• Respect: We will treat each other with respect.
• Understand: We will seek to understand and respond genuinely.

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)

American Heart Assoc. or American Red Cross CPR for Prof. Rescue

Within 3 Months of Start Date

Employee Provides HR a Copy

Education & Experience

Degree/Diploma

Program of Study

Required/Preferred

Experience

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

Physical Demands

Activity

Frequency

Sit

Frequently (34-66%)

Stand

Occasionally (5-33%)

Walk

Occasionally (5-33%)

Stoop/Bend

Occasionally (5-33%)

Reach

Frequently (34-66%)

Climb

Not Applicable

Crawl

Not Applicable

Squat/Crouch/Kneel

Occasionally (5-33%)

Twist

Occasionally (5-33%)

Handle/Finger/Feel

Frequently (34-66%)

See

Frequently (34-66%)

Hear

Frequently (34-66%)

Weight Demands

Activity

Amount

Lift - Floor to Waist Level

Light (10-20 pounds)

Carry

Light (10-20 pounds)

Push/Pull

Light (10-20 pounds)

Slide/Transfer

Light (10-20 pounds)

Working Conditions

Condition

Frequency

Indoor

Continuously (>67%)

Outdoor

Rarely (
Extreme Temperature

Rarely (

Functional Assessment

Type

Not Applicable