Clinical Research Coordinator

Description

GENERAL SUMMARY

 The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) and Clinical Research Manager. This position involves conducting, coordinating, and providing support for various clinical trials. The CRC is required to fulfill the following responsibilities while upholding Good Clinical Practice (GCP) standards and complying with FDA regulations: 

Responsibilities include but are not limited to:

• Participates in patient screening, recruitment, and enrollment

•Consent and conduct research visits

• Discretion and maintenance of patient confidentiality

•Responsible for collecting, processing, and shipping of research specimens, where applicable

•Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits

•Obtain, review, and maintain all related source documents and trial related correspondences

• Communication with research department and site managers/staff along with study sponsors

•Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting, Delegation of Authority, Training Logs, CV’s, Licenses, sponsor communication

• Maintain professional and technical knowledge about clinical trials

• Maintain and assist with calibration of equipment needed for various studies

• Daily maintenance of temperature monitoring

•Training interoffice staff/office sites on study protocol and workflows

•Assist with site workflows

•Maintain up to date certifications requirements- GCP, IATA and CP

Requirements

CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS

• BLS certification required, ACLS preferred.
• License and certification as required by state.
• Medical Assistant Certification

Minimum Education Required: 

Bachelor’s degree in health- related field or 2 years relevant

clinical experience

Preferred: 

Bachelor’s degree in health- related field or 3+ years relevant clinical research coordinator experience 

KNOWLEDGE | SKILLS | ABILITIES

• Knowledge of medical terminology, healthcare coding systems, and clinics functions.
• Must be able to function in a team-oriented environment, display strong analytical, investigative, interpersonal and organizational skills, pay high attention to detail with consistent follow-through and be able to productively manage high volumes of work.
• Knowledge of database management.
• Maintain a working knowledge of all assigned study protocols and amendments.
• Excellent verbal and written communication skills.
• Skill in using computer programs and applications including Microsoft Office.
• Delivers exceptional patient service throughout all interactions.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Complies with all health and safety policies of the organization.
• Complies with HIPAA regulations for patient confidentiality.
• Ability to work independently and manage deadlines.
• Ability to establish and maintain effective working relationships with patients, colleagues, physicians and the public; successfully manages interactions with challenging or difficult people.
• Ability to deal compassionately, professionally, and courteously with patients, their families, physicians, and staff.
• Ability to build relationships with patients and display empathy and compassion to patients.

EXPERIENCE REQUIREMENTS

• Experience with EPIC software preferred but not essential.
• 1-3 years of related experience preferred.