Clinical Research Specialist

Balboa Nephrology•Chula Vista, CA

2d•Onsite

About The Position

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.

Requirements

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, written, and verbal communication skills, including professional correspondence with CRO and Sponsor representatives.
Exhibits the capacity to work unattended and complete delegated tasks by specified deadlines.
Excellent verbal and written communication
Ability to provide excellent customer service
Ability to interpret, adapt and apply guidelines and procedures
Ability to use good reasoning and judgement and react appropriately in emergency situations
Ability to establish and maintain effective working relationships with patients, medical staff and coworkers
Regularly required to talk, hear, read, write, type and respond in English and understand clinical/medical vocabulary written and spoken.
Close vision, ability to adjust focus, and see color.

Nice To Haves

Experience in CKD, Dialysis, or Renal Transplantation.
Certification as a Clinical Research Associate or Coordinator.
Bachelor’s degree in a natural science (e.g., Biology, Chemistry, BSN).
Current certifications in Good Clinical Practice (GCP), the National Institute of Health (NIH), Shipping of Blood Specimens, and Blood Borne Pathogens (IATA).
Skilled in lab techniques, processing, and shipping of human biologics.
Established experience in medical terminology.
Bilingual in English and Spanish.

Responsibilities

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.