Classification: Exempt

Grade: 6

Reports to: Clinical Research Site Supervisor

Directly Supervises: This position does not have direct reports

This position is for serious inquiries only. Applicants who are certified though ACRP will be considered before those applicants that are not. We are looking for applicants with unparalleled work ethic and a "whatever-it-takes" determination. This position is not eligible for relocation expenses. Applicants may be asked to take a test to measure their skills as a Clinical Research Coordinator.

Expectation for all employees: To support the organization’s passionate cause, vision, and FUNdamentals by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect, accountability, and ownership. Employees are expected to be professional and collaborative.

Position Purpose: The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Clinical Research Site Supervisor and the Principal Investigator. The CRC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgement, and a high level of knowledge of study-specific protocols.

Essential Responsibilities:

Develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials

Provide results-oriented administration of operational activities to ensure quality and efficient services are provided

Facilitate professional, efficient service to patients and the clinical trial industry

Coordinate telephone and email communications

Input and process documentation regularly and accurately

Coordinate professional relationships with physicians, vendors, and industry representatives

Oversee patient enrollment and randomization for clinical trials and completion of required documentation

Ensure quality assurance (QA) and data integrity

Provide Sponsor, CRO and other industry representatives with usable data by converting patient’s source documentation into Case Report Forms (CRFs)

Coordinate and resolve all queries and problems associated with data submissions

Thoroughly prepare for all Sponsor, CRO, and FDA visits, including PSVs, SIVs, IMVs, COVs, and audits of all types

Serve as the point of contact for all stages of a clinical trial from pre-study through closeout

Display basic understanding of GCP/ICH Guidelines

Participate in the On-Call schedule

Perform local recruiting efforts for clinical trials

Solicit industry-sponsored trials through contacts and professional organizations

Direct the requisition, collection, labeling, storage, and/or shipment of specimens

Perform specific protocol such as interviewing patients, taking vital signs, and blood draws

Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics

Oversee patient enrollment to ensure that informed consent is obtained & documented

Perform internal monitoring duties on other CRC charts in order to reduce the number of data queries and issues

Assist the Clinical Research Administrative Specialists in correcting errors in source documents and CRFs

Serve as a resource to other CRCs and demonstrate abilities as a subject matter expert (SME)

Other duties and responsibilities as assigned

Minimum Position Requirements:

2 years of clinical research experience

CRC Certification with ACRP

Education: Appropriate education and/or experience may be substituted on equivalent basis

Required: HS/GED

Knowledge, Skills, & Abilities:

Demonstrated excellence in performing the duties of the Clinical Research Coordinator position according to company expectations and objectives. Ability to maintain professionalism and professional standards. Must have a sense of urgency. Set priorities. Identify and resolve problems effectively and efficiently. Excellent communication and organizational skills for managing workflow and follow-up. Ability to demonstrate reliability and maintain confidentiality. Possess temperament and emotional intelligence for dealing with others professionally. Must have a “do-what-it-takes” attitude. Excellent speaking skills to communicate clearly and effectively with patients, physicians, industry professionals, and others in person or over the phone.

Background Checks:

Background and criminal history check

Drug Screen

Others as needed

Physical Demands:

Manual Dexterity: Work requires moderate speed and accuracy, excellent keyboarding skill for computer use.

Physical Effort: Work requires considerable variety of fairly steady active physical exertion. Some and/or continuous standing or walking. Some lifting of items less than 20 lbs.

Working Conditions: Potential for early morning and/or late-night responsibility, occasional 24-hour on-call duty

Hazards: Potential exposure to blood and body fluid exposures.

Travel: Travel is not a regular expectation of this position