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Bilingual Clinical Research Coordinator

2 months ago

Farmers Branch, United States Medix™ Full time

Summary:


Seeking a Clinical Research Coordinator who will be responsible for managing the day-to-day operations of assigned clinical trials, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and screen study participants, as well as document and report on the daily operations of a study and participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information.

The Clinical Research Coordinator I must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the PCR team, pharmaceutical sponsors, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team-player, and manage multiple projects effectively and efficiently. This role reports directly to the Clinical Research Project Manager.

Duties and Responsibilities:

Clinical Trial Execution:

  • Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Project Manager, and Director of Clinical Research Operations
  • Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures
  • Complete study directed assessments with patients which include, but not limited to, informed consent, subject history, adverse events, Fibroscan, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment
  • Create and complete study related documents and new study preparation
  • Function as a liaison with pharmaceutical sponsors and external vendors
  • Prepare for study monitor visits (onsite or remote), audit inspections, etc.
  • Respond to internal and external requests for information in a timely manner
  • Perform subject screening and recruitment
  • Contribute to data management for research projects
  • Identify opportunities to improve patient care and satisfaction
  • Conduct patient-facing encounters with compassion, empathy, and thoroughness
  • Must be able to review medical records against Inclusion/exclusion criteria to identify potential subjects
  • Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose
  • Obtains and documents adverse event data on appropriate forms
  • Ensure source documents are transcribed to EDC platform per protocol on a timely manner
  • Ensure EDC queries are answered within the required time set by the Project Manager or Data Management team
  • Resolve other study-related queries within a reasonable time set by the Project Manager or Data Management team
  • Interact with internal and external personnel such as physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients
  • Coordinate multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume
  • Attends the investigator’s meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by Monitors or Sponsor representatives as appropriate

Administration:

  • Ensure that electronic case report forms are completed
  • Create memos, emails, and letters related to study activities
  • Create and maintain reports and/or spreadsheets as requested
  • Ensure that all patient data is entered into the clinical trial management system in a timely manner
  • Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections
  • Responsible for reporting safety information to all regulatory agencies
  • Understand the aspects of Regulatory and IRB requirements for studies
  • Performs quality checks on source documents specific to the study
  • Assist with the Corrective Action Preventive Action Plan (CAPA) process as needed