Research Assistant

Overview:

Peninsula Research Associates (PRA) is dedicated to improving medical treatments through the use of innovative techniques and awareness. PRA strives to educate patients on a vast array of health-related issues with the goal of enriching the quality of life and creating the potential for new opportunities.

Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion.

The Role

The Research Assistant is integral in maintaining the integrity of data collection, patient care, and adherence to study protocols, contributing to advancements in clinical research.

Location: Rolling Hills Estates, CA (no remote work)

Work Schedule: Monday- Friday 8:00am - 5:30pm

Responsibilities:

• Study Preparation
• Prepare and maintain study documents, including source charts, study binders, regulatory binders, and laboratory kits.
• Schedule and confirm subject appointments, including ancillary visits such as diagnostic imaging and vendor-related services.
• Understand study protocols, inclusion/exclusion criteria, and regulatory requirements, ensuring compliance with FDA, Sponsor, and Good Clinical Practice (GCP) guidelines.
• Assist in participant recruitment by prescreening electronic medical records, following up on referrals, and coordinating outreach efforts.

• Provide subject care, including explaining study procedures, answering questions, and monitoring diary compliance.
• Conduct study procedures, such as collecting vital signs, performing ECGs, and completing study questionnaires.
• Perform follow-up and reminder calls to ensure subject adherence to visits and study protocols.
• Assist with participant stipend tracking and processing.

• Perform blood draws (if qualified) and process biological samples, including shipping per study requirements.
• Maintain laboratory equipment, supplies, and temperature control systems, ensuring compliance with study protocols.
• Generate and file weekly temperature reports for laboratory systems.

• Enter and verify study data in Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), and other databases.
• Address system-generated queries and perform quality control checks to ensure data accuracy and completeness.
• Assist with case report forms (CRFs) and source document completion, including query resolution under study coordinator guidance.

• Maintain and organize participant charts, Investigator Site Files, and other regulatory documents.
• Support clinical research coordinators (CRCs) by filing, scanning, and faxing required documents.
• Clean, stock, and maintain exam rooms and department supplies to ensure readiness for participant visits.
• Participate in investigator meetings, study teleconferences, and trainings.
• Assist with onsite or remote clinical research monitor visits.

Qualifications:

• Education & Experience: Bachelor’s degree preferred or equivalent experience; 1–2 years in clinical research or healthcare required.
• Medical Knowledge: Familiarity with medical terminology, lab procedures, and research protocols.
• Attention to Detail: Ability to collect, compile, and analyze data accurately.
• Communication & Customer Service: Strong interpersonal, verbal, and written communication skills.
• Technical Skills: Proficiency in Microsoft Office and Electronic Data Capture (EDC) systems.
• Adaptability & Problem-Solving: Ability to prioritize tasks, meet deadlines, and work in a fast-paced environment.
• Collaboration & Independence: Comfortable working both independently and within a team.
• Compliance & Confidentiality: Understanding of HIPAA, FDA, GCP, and ICH guidelines (preferred).
• Research & Lab Skills: Basic computer literacy, with lab skills (e.g., blood draws, specimen processing) preferred.
• Certifications (Preferred): BLS/CPR, CNA, CMA, or similar certification.