Position Title: Assoc Spec, Clinical Research Work Location: Irvine, CA 92606 Assignment Duration: 16 Months Work Arrangement: Hybrid (Monday - Tuesday will be onsite)
Position Summary: 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).
Key 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, our organization 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.
Qualification & Experience:
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 based on our organization criteria.
Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)
Experience with electronic data capture
Good computer skills in usage 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 our organization 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
Bachelor's Degree or equivalent in related field
0-2 years of experience required
Applicant Notices & Disclaimers
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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 pay range is $40.00/hr - $42.15/hr.
