Clinical Research Coordinator

4 weeks ago

Encinitas, United States Diagnamics, Inc. Full time

Clinical Research Coordinator

Full-time, on-site position in San Diego, CA

A Clinical Research Coordinator works as the lead on studies of varying disease types, providing a range of study related services, and assisting the investigator or other staff with aspects of sponsor initiated research studies.


Key Responsibilities:

  • Assist in coordinating participant activities including recruitment, screening for eligibility criteria, informed consent process, and all study visit requirements.
  • Ensure the informed consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, sponsor and site SOP's.
  • Collect, record, and maintain accurate records and study data including source documents, case report forms, protocol documents, and regulatory documents.
  • Update automated databases and other records for reporting, recruitment, and compliance purposes.
  • Evaluate subject adherence to study requirements and promote compliance through ongoing education.
  • Assist with timely submissions of accurate and complete study continuing review, amendments, and reportable events to the IRB.
  • Prepare for monitoring visits and external/internal audits by reviewing regulatory and source documents frequently.
  • Provide timely responses to queries from sponsor and/or auditors.
  • Maintain accurate accountability of investigational products, specimens, and study related supplies.
  • Maintain inventory and order supplies and equipment.
  • Attend Investigator meetings and other events related to project efforts.
  • Participate in educational opportunities to increase knowledge about clinical trials and regulations.
  • Remain current with federal, state, and institutional regulations and best practices.
  • Work with the study team to ensure study procedures are followed and research is performed as described in the protocol.
  • Serve as contact for subjects, study personnel, IRB, and study sponsor.
  • Assist with sample collection, processing, and shipment for each study.
  • Maintain social media accounts including Facebook, Instagram, and LinkedIn.
  • Create advertisement material to post on social media for recruitment purposes.
  • Performs other related duties as assigned or requested.


Qualifications:

  • BS/BA or relevant work experience
  • Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens
  • Excellent attention to detail and organization
  • Demonstrate effective communication and writing skills
  • Knowledge of medical environment and terminology
  • Ability to multitask
  • Willingness to learn, take initiative, and be proactive
  • Demonstrated ability to work as part of a team as well as independently
  • Knowledge and understanding of federal & state research regulations as well as GCP and HIPAA regulations
  • Spanish speaker not required but preferred

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