Clinical Research Assistant- Irvine, CA

Job description

• This role is for a clinical research assistant who will be in charge of the implementation of human research study activities in accordance with the approved protocols, applicable regulatory regulations and GCP guidelines.
• The candidate will work closely with multidisciplinary team members to facilitate activities related to one or more research projects.

Work with Principal Investigator and Engineering team to facilitate daily activities and comply with research protocols;

• Lead recruitment and enrollment of subjects for internal data collections including posting advertisements and scheduling subjects;
• Organization and maintenance all research study documents including data entry, routine data verification and quality control;
• Support engineering data collection focused on usability and repeatability with prototypes on employees;
• Assists in preparation of detailed reports surrounding study, study progress and findings;
• Maintain clinical supplies for internal studies;
• Manage diagnostic instrumentation requiring calibrations, QCs, and preventative maintenance;
• Assists in the preparation and submission of all study documentation for IRB approval of internal studies;

KNOWLEDGE, SKILLS, AND ABILITIES

• The Clinical Research Assistant is developing professional expertise and applies working knowledge to solve problems of moderate to difficult scope where analysis of situations or data requires a review of a variety of factors.
• The Clinical Research Assistant accomplishes tasks of moderate technical complexity and exercises judgment within defined procedures and practices to determine appropriate action.
• The Clinical Research Assistant requires low supervision and normally receives general instructions on routine work and detailed instructions on new projects or assignments.
• Work is generally reviewed upon completion.
• The Clinical Research Assistant builds productive internal/external working relationships.

EDUCATION & EXPERIENCE

• Minimum 2 years of experience as a clinical research assistant or similar role;
• Knowledge and experience with Good Clinical Practices (GCP), HIPAA;
• Experience running internal clinical trials including patient recruitment, scheduling, and data collection process;
• Ability to work in a fast-paced environment both independently and in a group setting with minimal direction the flexibility to adjust to workload based upon changing priorities;
• Excellent interpersonal, verbal, and written communication skills;
• Great organizational and time management skills;

Contract: Until the end of the year with possible extension

Hours approximately: 40

Location: Irvine, CA

Job Types: Full-time, Contract

Hourly Rate: $30-$40 hourly

Schedule:

8 hour shift

Work Location: Onsite