Apex Research

Benefits:

• 401(k)
• Employee discounts
• Health insurance
• Paid time off

Employment Type: Full-Time
Location: Lancaster, California
Position Summary
Apex Research Inc. is seeking a motivated and detail-oriented Clinical Research Assistant (CRA) to support the daily operations of clinical research studies. The Clinical Research Assistant will work closely with Clinical Research Coordinators, Principal Investigators, Sub-Investigators, sponsors, and other research staff to help ensure studies are conducted efficiently and in accordance with study protocols, Good Clinical Practice (GCP), IRB requirements, and company policies.
This is an excellent opportunity for someone interested in developing a career in clinical research. Previous clinical research experience is preferred but not required. Training will be provided.

Essential Duties and Responsibilities
The Clinical Research Assistant will assist the research team with responsibilities including:

• Assist Clinical Research Coordinators with day-to-day clinical trial activities.
• Review clinic and procedure schedules to identify potential study participants.
• Assist with patient recruitment, including telephone calls, text outreach, and in-office recruitment.
• Conduct basic patient pre-screening using study inclusion and exclusion criteria under the direction of the Clinical Research Coordinator.
• Schedule research visits and provide appointment reminders to study participants.
• Prepare study documents and materials before participant visits.
• Assist with collecting demographics, medical history, medication information, and other study-related information as delegated.
• Obtain and document vital signs, height, and weight when appropriately trained and delegated.
• Assist with blood draws and specimen collection, processing, packaging, and shipping after appropriate training and competency documentation.
• Assist with maintaining accurate and organized source documentation.
• Enter study information into electronic data capture (EDC), CTMS, and other research systems as assigned.
• Assist with resolving missing documentation and data queries under coordinator supervision.
• Maintain study binders, regulatory documents, training records, logs, and other essential study documentation.
• Assist with tracking patient visits, study payments, gift cards, laboratory kits, supplies, and study inventory.
• Help prepare for sponsor monitoring visits, audits, site initiation visits, and study closeout activities.
• Maintain patient confidentiality and comply with HIPAA requirements.
• Complete required study, protocol, GCP, HIPAA, and company training.
• Communicate professionally with patients, investigators, research staff, sponsors, CROs, and other study partners.
• Assist with additional clinical research duties as assigned by the Clinical Research Manager or Clinical Research Coordinator.

Qualifications

• High school diploma or equivalent required.
• Medical Assistant certification, healthcare education, or college coursework in a health/science-related field is preferred but not required.
• Previous experience in a medical office, clinical setting, or clinical research environment is preferred.
• Clinical research experience is not required for the right candidate willing to learn.
• Strong organizational skills and attention to detail.
• Ability to follow written protocols, procedures, and instructions.
• Comfortable working directly with patients.
• Strong verbal and written communication skills.
• Basic computer skills and ability to learn electronic research systems.
• Ability to manage multiple responsibilities and prioritize tasks.
• Must maintain professionalism and patient confidentiality at all times.
• Bilingual English/Spanish is preferred.

Preferred Skills

• Phlebotomy or blood-draw experience.
• Medical Assistant experience.
• Knowledge of medical terminology.
• Experience with electronic medical records (EMR/EHR).
• Familiarity with clinical research, GCP, HIPAA, IRB requirements, or FDA-regulated research.
• Experience working in gastroenterology or other outpatient medical specialties.
• Strong patient communication and customer service skills.

Training and Development
The Clinical Research Assistant will receive training appropriate to assigned responsibilities. Training may include:

• Good Clinical Practice (GCP)
• Human Subjects Protection
• HIPAA and patient confidentiality
• Clinical research documentation
• Study protocols
• Patient recruitment and pre-screening
• Electronic research systems
• Specimen handling and processing
• Clinical research regulatory requirements
• Site-specific policies and SOPs

As competency and experience increase, additional clinical research responsibilities may be delegated under appropriate supervision.
Physical Requirements
The position may require prolonged periods of sitting or standing, computer use, walking throughout the clinic, handling research supplies, and assisting with clinical research procedures. The employee must be able to perform the essential functions of the position with or without reasonable accommodation.
Professional Expectations
The Clinical Research Assistant is expected to demonstrate reliability, professionalism, confidentiality, teamwork, and attention to detail. All research staff are expected to work collaboratively across studies and assist the research department as needed rather than working exclusively on one assigned clinical trial.
Equal Employment Opportunity
Apex Research Inc. is an equal opportunity employer and considers qualified applicants without regard to legally protected characteristics in accordance with applicable federal, state, and local laws.