Position Title: Clinical Research Coordinator 3
Work Location: Loma Linda, CA, 92354
Assignment Duration: 12 Months
Shift: Mon-Fri 8 am - 5 pm
Additional Skills/Qualifications: Prior oncology clinical trial experience, EDC experience, biospecimen handling and shipping experience

Summary:

• 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, standard operating procedures (SOPs), and Good Clinical Practice (GCP).
• Assist with daily workload planning.

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Responsibilities

• Provide clinical research support to investigators to prepare for and execute assigned research studies, including:
  • Review 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
  • 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.

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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
  • Word
• Excellent interpersonal skills
• Ability to pay close attention to detail
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

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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

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 30.00/hr.