Clinical Research Coordinator

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

License, Certificates, & Training:

Certified Clinical Research Coordinator

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.