Clinical Research Coordinator

Job Description

Job Description

Description : Job Description

Job Title : Clinical Research Coordinator (CRC)

Department : Clinical Research

Reports to : Clinical Manager

Summary : The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the clinical Principal Investigator's (PI) direction. While the principal investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel, and other related aspects of the clinical study.Essential Duties and Responsibilities

• Rights, safety and well-being of patients prevail over science.
• Rights, safety and well-being of patients prevail over science.
• All available non-clinical and clinical information on any investigational agent can support the trial as designed.
• All trials are scientifically sound and clearly described.
• All clinical trials have current Institutional Review Board approval.
• Everyone involved in the clinical Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians.
• Trial is qualified by training, education and experience.
• Informed consent is given freely by every participant.
• All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
• Confidentiality of subjects is respected and protected.
• Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling.
• Systems to ensure quality are implemented in all aspects of the trial.
• Register participants to the appropriate coordinating center (if multi-site study)
• Complete study documentation and maintains study files in accordance with sponsor requirements and policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms and investigational material accountability forms.
• Retains all study records in accordance with sponsor requirements.
• Maintains effective and ongoing communication with sponsor, research participants, research director and PI during the course of the study.

Competencies Required :

Qualifications / Education / Experience :

Qualifications :

High school graduate or equivalent.

Supervisory :

The incumbent in the position will not supervise other employees.

Education / Experience :

Bachelor’s degree in life science or related discipline and experience in clinical research is preferred.

Skills / Abilities : Language Ability :

Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. Knowledge of modern equipment and the ability to maintain confidentiality, maintain physical effort, and distribute files.

Math Ability :

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent, and to draw and interpret bar graphs.

Reasoning Ability :

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills :

Proficient in Microsoft Office, Outlook, Excel, PowerPoint, and Word; able to navigate the internet and intranet. Ability to learn the internal clinical outcome database and upload photographs from a camera.

Environment Expectations :

Work Environment :

The incumbent in this position is not required to work under extreme conditions, but must be able to work around a moderate noise level, such as in an office environment.

Physical Demands :

The incumbent in this position typically has to stand approximately 20% of the time, walk 20% of the time, and sit 60%. In addition, this person talks or hears 100% of the time.

Accountability :

The Clinical Research Coordinator is accountable for the day-to-day operations of ensuring the clinical trial program runs smoothly, via phone messages, faxes to physicians and staff, database entry, billing entry, etc.

Specific Individual Considerations :

The designation of "essential functions" and "other duties" is for purposes of compliance with the Americans with Disabilities Act. This job description should not be construed to imply that these requirements are the only duties, responsibilities, and qualifications for this position. Incumbents may be required to follow any additional related instructions, acquire related job skills, and perform other related work as required. Incumbents in this position may be required to perform all or some of the above duties and responsibilities with varying concentration levels based on the incumbent's skill level and program needs.

I have read and understand the contents of this position description.

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Requirements :