Clinical Research Associate

TalentBurst•Irvine, CA

10d•Hybrid

About The Position

The main function of a clinical research specialist is to perform study start-up and conduct activities, including ICF review that meet regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities.

Requirements

Bachelor's Degree or equivalent in related field
Bachelor's Degree or equivalent with 1 year of experience in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry or equivalent work experience.
0-2 years of experience required

Nice To Haves

Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)
Experience with electronic data capture
Good computer skills in the use of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master File)
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills
Good knowledge and understanding of the client's policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
Good understanding of regulatory submissions, reporting, and audits
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
Ability to build productive internal/external working relationships

Responsibilities

Participating in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit).
Conducting reviews of documentation needed for internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential Clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, the client's internal SOPs, and US and OUS regulations.
Investigating discrepancies and participating in the development of processes to minimize possibility of recurrence during study conduct and closeout.
Assisting in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas.