Clinical Research Specialist

• Balboa Nephrology is the largest kidney care practice in California and participates in a national Medicare program focused on value-based care.
• Through our joint venture with Evergreen Nephrology we are a growing organization with opportunities for professional and personal growth.
• We will help you grow in your leadership experiences while learning the new value-based care world.
• Join a fast-growing field - employment of medical and health services managers is projected to grow 32 percent from 2020 to 2030, much faster than the average for all occupations.
• Voted 4 years in a row as a Top Workplace of San Diego !

Patient-centered I Accountability I Respect I Innovation I Data-Driven

to consistently deliver superior care –Balboa Care– to every patient with kidney disease.

The temp-to-hire Clinical Research Specialist operates with greater independence than the Research Assistant, taking on expanded clinical and administrative responsibility across delegated trials under the supervision of the Clinical Research Coordinator and Principal Investigator. The Specialist conducts study visits, manages source documentation, and independently reviews data for completeness and quality, serving as a bridge between entry-level trial support and full coordinator-level responsibility.

• Timely and accurate EDC, CTMS, and study-related vendor portal data entry.
• Cross-checking data across online portals and vendor systems for accuracy.
• Subject visit tracking and scheduling per protocol.
• Creation, recording, reporting, and cataloging of source documentation.
• Maintains and manages trial-specific source documentation and study binders.
• CRO and Sponsor scheduling and correspondence support for the Clinical Research Coordinator.
• Identifies and communicates protocol or data management issues to the supervisor in a timely manner.
• Assists in maintaining federal and GCP/ICH compliance during the conduct of trials.

• Independently performs, records, and reports delegated study visit tasks per protocol (e.g., subject intake, EKGs, trial-specific biologic sample collection).
• Collects, processes, and ships trial-specific biologic samples per protocol.
• Assists the PI and Clinical Research Coordinator in subject recruitment, screening eligibility, informed consent, and subject retention.
• Responsible for the collection and reporting of subject data and AE/SAEs within accepted guidelines.
• Completes all required training per protocol during pre-study, enrollment, and closeout phases.

Pay Range: $

Location and Type: In person, Temporary full-time role with potential for hire

• 1–2 years of clinical research experience, preferably in clinical research, human medicine, or end-stage disease, or an equivalent combination of education and experience.
• Valid driver’s license and dependable transportation to travel locally between sites.
• Demonstrated ability to independently conduct study visits and delegated procedures per protocol (e.g., subject intake, EKGs, biologic sample collection).
• Experience with study protocols and a record of successful collection, recording, and reporting of data with written and online databases (EDC, CTMS).
• Demonstrated experience independently reviewing data for completeness and quality assurance related to the collection and reporting of clinical data.
• Experience interpreting medical charts and obtaining data from medical records.
• Experience in HIPAA and GCP/ICH, including federal and local record management.
• Understanding of FDA, ethics, and regulatory requirements governing clinical trials.
• Demonstrated interpersonal,…