Clinical Research Coordinator (Onsite) - HCA Florida Northside

Job Description

Shift : M-F 7am to 4pm – hours may be adjusted by Hiring Division Director

Onsite Address: 6000 49th Street North, St. Petersburg FL 33709

Position Summary

The Research Coordinator position is responsible for Coordinating multiple research protocols and serving as a liaison with local investigators and Sponsors.  Under direct supervision, this individual will mature in their understanding of research operations and regulations in order to achieve a fundamental understanding of human subject research.

Major Responsibilities:

Duties include but are not limited to:

•         Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”

•         During your employment with HRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.

•         Performs routine operational activities for multiple research protocols

•         Liaise between site research personnel, industry sponsors, and Supervisor

•         Collaborates closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable

•         Coordinates schedule of assessments from initial submission of feasibility until study closeout

•         Reviews the study design and inclusion/exclusion criteria with physician and patient

•         Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements

•         Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data

•         Creates study specific tools for source documentation when not provided by sponsor

•         Collects, completes, and enters data into study specific case report forms or electronic data capture systems

•         Generates and tracks drug shipments, device shipments, and supplies as needed

•         Ensures timely and accurate data completion

•         Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations

•         Communicates all protocol-related issues to appropriate study personnel or manager

•         Attends study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings, as required

•         Reviews and responds to any monitoring and auditing findings

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Education & Experience:

 

•         Bachelor’s Degree

Required

 

•         Degree

Preferred

 

•         1+ years of relevant experience

Required

Or equivalent combination of education and/or experience

Licenses, Certifications, & Training:

 

•         Certified Clinical Research Coordinator

Preferred

Knowledge, Skills, Abilities, Behaviors:

Knowledge:

•         Knowledge of organizational policies, standard operating procedures, and systems

•         Emerging understanding and application of ICH guidelines and the Code of Federal Regulations within the clinical research environment.

•         Basic understanding of medical terminology

Skills: The proficiency to perform a certain task

•         Effective communication skills

•         Strong organizational skills and time management

•         Basic clinical trial procedures, including ECG acquisition, phlebotomy, and specimen processing, handling, storing, and shipping

Abilities: An underlying, enduring trait useful for performing duties

•         Interpersonal skills

•         Self-motivated

•         Meticulous eye for detail

Clinical Competencies: This role may require competency in performing clinical tasks, including ECG, phlebotomy, and the process of handling, centrifuging, storing and shipping of specimens. Demonstrating the ability to perform core competencies will be evaluated, at a minimum, annually. Training and/or certification will be provided when mandatory, per protocol.

Travel Required

Check the frequency of travel required of the employee to perform the essential functions of the job.

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No Travel: The job does not require any travel.

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Occasional Travel: The job may require travel from time- to-time, but not on a regular basis.

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The job may require up to 25% travel.

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The job may require up to 50% travel.

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The job may require up to 75% travel.

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The job may require 76% or more travel.