Job Title: Sr. Clinical Research Coordinator

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Company: Comrise

Location: Riverside, CA 92503

Description:

Job Title: Sr. Clinical Research Coordinator

Job Num: 29757

Job Category: Other

Job Location:

City : Riverside

State : CA

Country : United States

Postal Code :

Overview:

Summary:

The Senior Clinical Research Coordinator is responsible for coordinating multiple research protocols; serving as a liaison with local investigators and research personnel; and acting as a central resource for assigned research projects. The individual in this role offers a significant contribution to the development of processes, tools, and training necessary to maintain site compliance and patient safety.

Responsibilities:

Major Responsibilities:

  • Practices and adheres to the "Code of Conduct" philosophy and "Mission and Value Statement"
  • Demonstrate ability to fulfill responsibilities and duties of the CRC Level I and II
  • Assist with training CRC Level I and II personnel
  • Act as a role model to peers Clinical Research Operations
  • Perform routine operational activities for multiple research protocols
  • Liaise between site research personnel, industry sponsors, and Supervisor
  • Collaborate closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable
  • Coordinate schedule of assessments from initial submission of feasibility until study closeout
  • Coordinate submission and approval for the Site's Facility Review Committee, if applicable
  • Provide awareness of research protocols to appropriate site-level personnel, including physicians, nurses, clinical staff, and administrators
  • Document all specific tasks required by the protocol (i.e. medication forms, quality of life questionnaires, neuro exams, vital signs sheets, times of lab draws, etc.)
  • Accurately perform/calculate and documents the BSA, mRS, NIHSS, STS risk score, or any other approved CRC task, as needed per protocol
  • Document all patient, staff, and sponsor correspondence, including follow-up encounters, adverse events, interventions, pharmacy dispensations, and patient phone calls
  • Ensure follow-up appointments, imaging, or any related procedures are scheduled correctly according to protocol requirements
  • Accurately complete all data requests (including queries) and submit with source documentation within the timeframe specified in the SOP
  • Re-consent patients in a timely manner and document process appropriately Support study team in mitigating risks and optimizing site compliance, Site Development
  • Work with site personnel and local investigators to assess site feasibility and performance
  • Regularly meet with physicians and administrators, when applicable, to assess study performance and investigator satisfaction
  • Collaborate with other departments (non-invasive, finance, laboratory, etc.) to develop and implement processes in support of the research activities
  • Assist with providing a research update during Site Administrative meetings (Section meetings, Site Service Line meetings, etc.)
  • Able to guide research team members on the management of non-compliant data and/or study activities
  • Reporting and Analysis
  • Monitor patient enrollment at the site through weekly reports, and reports results to Supervisor
  • Facilitate continuing education and training to investigators, as applicable


Qualifications:

Education & Experience:

  • Bachelor's Degree - Required
  • Master's Degree - Preferred
  • 1+ years of relevant experience - Required
  • 5+ years of relevant experience - Preferred

OR equivalent combination of education and/or experience

Licenses, Certifications, & Training:

  • Certified Clinical Research Coordinator (ACRP or CCRP)


Knowledge, Skills, Abilities, Behaviors:

Knowledge:

  • Knowledge of organizational policies, standard operating procedures, and systems
  • Demonstrate understanding and application of ICH guidelines and the Code of Federal Regulations within the clinical research environment.
  • Fundamental understanding of medical and research operations terminology
  • Recognize circumstances requiring prompt escalation to PI, IRB, and/or Supervisor


Skills:

  • Effective communication skills
  • Strong organizational skills and time management
  • Basic clinical trial procedures, including ECG acquisition, phlebotomy, and specimen processing, handling, storing, and shipping.
  • Effective interfacing with site stakeholders


Abilities:

  • 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

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