Job Details
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