Clinical Research Coordinator

Key Details:

• 100 % ONSITE, NOT open to out of state applicants
• Phlebotomy experience highly preferred but not required

Clinical Research Coordinator (CRC)

The Clinical Research Coordinator is responsible for supporting the successful execution of assigned clinical trials in compliance with GCP and ICH guidelines, HIPAA, FDA regulations, and internal standard operating procedures (SOPs).

Key Responsibilities

Working collaboratively with the clinical research team, the CRC plays a vital role in managing day-to-day study activities. Core duties include, but are not limited to:

• Screening and enrolling patients for clinical studies
• Obtaining informed consent from study participants
• Coordinating and conducting patient follow-up visits
• Accurately documenting clinical data in source charts
• Entering study data into electronic data capture (EDC) systems and resolving queries
• Collecting vital signs and electrocardiograms (ECGs)
• Performing basic lab procedures per protocol, such as:
• Collecting and processing blood specimens
• Operating a centrifuge
• Preparing, storing, and shipping lab samples
• Managing specimen accountability and courier coordination
• Managing medical record requests and tracking responses
• Maintaining study documentation, including logs and chart filings
• Ordering and organizing study-specific supplies
• Scheduling study visits and confirming appointments with participants
• Developing and updating source documentation as needed
• Supporting monitoring visits and addressing issues promptly
• Ensuring timely review of reports and patient results by the investigator
• Filing serious adverse event (SAE) and protocol deviation reports with sponsors and IRBs as required
• Documenting and reporting adverse events and any instances of non-compliance
• Communicating effectively with internal teams and external stakeholders
• Maintaining accurate, complete, and timely documentation in accordance with ALCOAC principles
• Assisting with study recruitment, patient enrollment, and tracking as needed
• Upholding the confidentiality of patient, client, and company information
• Completing other assigned duties as required

Study Start-Up and Meeting Support

• Completing all tasks necessary for study initiation, including required training and proper documentation in the Investigator Site File (ISF)
• Preparing for and participating in Site Initiation Visits (SIVs) and Investigator Meetings (IMs)
• Setting up, training on, and maintaining technology used in study operations

* We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

* As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.