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
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.
No Travel: The job does not require any travel.
Occasional Travel: The job may require travel from time- to-time but not on a regular basis.
The job may require up to 25% travel.
The job may require up to 50% travel.
The job may require up to 75% travel.
The job may require 76% or more travel.
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 ...
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
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.
No Travel: The job does not require any travel.
Occasional Travel: The job may require travel from time- to-time but not on a regular basis.
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Monthly Salary:
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