Clinical Research Coordinator

SPECTRAFORCE; Loma Linda (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

A healthcare staffing agency is seeking a Clinical Research Coordinator 2 in Loma Linda, California. The role requires prior oncology clinical trial experience, proficiency with EPIC and EDC systems, and strong interpersonal skills. Responsibilities include collecting and interpreting patient data, recruiting for clinical trials, and ensuring compliance with regulatory standards. Ideal candidates will have attention to detail and the ability to work effectively within a team. This is a 6-month position with a focus on quality in clinical research.

Qualifications

• Prior oncology clinical trial experience preferred.
• Experience with EPIC and EDC (iMedidata/RAVE).
• Biospecimen handling and shipping experience.

Responsibilities

• Perform clinical procedures to collect and report patient data.
• Assist with planning and executing research studies.
• Recruit and screen patients for clinical trials.
• Monitor subject safety and handle lab logistics.
• Provide training to new site staff on study specifics.

Skills

Knowledge of clinical trials

Excellent interpersonal skills

Attention to detail

Proficiency in MS Windows and Office applications

Education

High school diploma or equivalent

BS in a relevant field (preferred)

Job description

Overview

Position Title: Clinical Research Coordinator 2

Assignment Duration: 6 Months

Additional Skills/Qualifications: Prior oncology clinical trial experience and prior cellular therapy experience a priority. EPIC experience. EDC experience (iMedidata/RAVE), biospecimen handling and shipping experience. The worker will also occasionally be moving around campus with the patient.

Responsibilities

• Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, SOPs, and Good Clinical Practice (GCP).
• Assist with daily workload planning.
• Provide clinical research support to investigators to prepare for and execute assigned research studies, including review of study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data.
• Attend all relevant study meetings.
• Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research.
• Recruit and screen patients for clinical trials and maintain subject screening logs.
• Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits.
• Design and maintain source documentation based on protocol requirements.
• Schedule and execute study visits and perform study procedures.
• Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness.
• Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics.
• Monitor subject safety and report adverse reactions to appropriate medical personnel.
• Correspond with research subjects and troubleshoot study-related questions or issues.
• Participate in huddles to confirm daily study tasks are assigned to team members and are executed to the expected standards.
• Assist with study data quality checking and query resolution.
• Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring.
• Record, report and interpret study findings appropriately to develop a study-specific database.
• Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards.
• Provide training to new investigator site staff members on study-specific topics and requirements.
• Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
• Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.
• Assist research site with coverage planning related to staffing and scheduling for research projects.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of clinical trials. In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules.
• Knowledge of medical terminology.
• Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word.
• Excellent interpersonal skills.
• Ability to pay close attention to detail. Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• High school diploma (A BS would be a plus) or educational equivalent and relevant work experience in a clinical environment or medical setting; or equivalent combination of education, training and experience.
• Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies.