Clinical Research Coordinators

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

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.