Clinical Research Associate

Creative Solutions Services, LLC; Irvine (CA); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Creative Solutions Services, LLC in Irvine, CA is seeking an Associate Clinical Research Specialist to support study start-up activities and ensure regulatory compliance across TMF and site readiness.

The role requires strong attention to detail, teamwork, and the ability to manage multiple priorities in a fast-paced environment, with a hybrid onsite/remote arrangement (2 days onsite, 3 days remote).

Qualifications

• Bachelor's degree or equivalent in a related field.
• 1 year of clinical research experience (CRC/CRA) with QA/regulatory compliance.
• 0-2 years of experience required.

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).
• Investigation of discrepancies and participation in development of processes to minimize recurrence during study conduct and closeout.
• Assisting in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas.

Skills

Clinical research

Regulatory compliance

Documentation control

Quality assurance

Communication skills

Education

Bachelor's degree or equivalent in related field

Tools

CTMS

eTMF

MS Office

Job description

Position: Associate Clinical Research Specialist, Req# 18739-1

Location: Irvine, CA (2 days onsite, 3 days remote)
Duration: 16+ monthcontract withthe possibility of extension/conversion

Job Description

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.

Education and Experience

• 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

What else we look for (Preferred):

• 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

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, 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.