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

Diagnamics, Inc.

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Clinical Research Coordinator