Associate Clinical Research Specialist

We are looking for Associate Clinical Research Specialist for our client in Irvine, CA

Job Title: Associate Clinical Research Specialist

Job Location: Irvine, CA

Job Type: Contract

Job Overview:

Pay Range: $38.57hr - $43.57hr

Requirement/Must Have:

• Bachelor's Degree or equivalent with 1 year of experience in clinical research (as a CRC or CRA).
• Experience including quality assurance/control and regulatory compliance within the healthcare industry.

Responsibilities:

• Participating in study start-up activities including tracking site readiness and communicating with clinical trial sites regarding planning and logistics of site qualification and initiation visits.
• Conducting reviews of documentation needed for internal and competent authority audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, 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.

Nice to Have:

• Clinical research certification (ACRP or SoCRA, clinical coordinator/CRA certification).
• Experience with electronic data capture.
• Proficiency in MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master file).
• Good knowledge and understanding of organizational policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols.
• Good understanding of regulatory submissions, reporting, and audits.

Skills:

• Quality assurance/control.
• Regulatory compliance.
• Trial Master File (TMF) management.
• Good Documentation Practices.
• Clinical Trial Management System (CTMS).
• Electronic Data Capture (EDC).
• Problem-solving and critical thinking skills.
• Attention to detail.
• Strong verbal and written communication skills.
• Ability to communicate effectively with stakeholders.

Qualification And Education:

• Bachelor's Degree or equivalent in a related field.
• 1-2 years of experience required.
• Ability to manage confidential information with discretion.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to work effectively in a team environment.
• Ability to build productive internal and external working relationships.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities