Enter a job title or keyword

Clinical Study Research Specialist Onsite (Urgent Need)

Millenniumsoft

Job Location:

Irvine, CA - USA

Monthly Salary: Not provided by the employer

Posted: 13 July 2026 (30+ days ago)

Application Deadline: 14 October 2026

Vacancies: 1 Vacancy

Job Summary

Job Title - Spec 3 Clinical Research

Job Location:Irvine California
Duration: 12 Months

Job Description -

The main function of the Clinical Research Specialist is to support clinical study startup execution and closeout with a strong emphasis on maintaining an inspectionready Trial Master File (TMF).

Responsibilities include organizing reviewing and qualitychecking essential documents in the eTMF and CTMS to ensure compliance with GCP regulatory requirements and internal SOPs. The Specialist identifies and investigates documentation discrepancies supports data review and query resolution with crossfunctional teams and contributes to process improvements that enhance efficiency and documentation quality across clinical studies.

Key Responsibilities:
Participate 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 and other associated supporting tasks) as well as study execution and closure activities. Organize and manage documents in the Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) to ensure compliance with internal procedures. Review clinical data for completeness across multiple research trials and conduct thorough documentation reviews for internal and external audits (e.g. FDA TUV PMDA) to ensure all essential Trial Master File (TMF) documents adhere to Good Documentation Practices Edwards internal SOPs and relevant US and OUS regulations.

Review identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study conduct and closeout

Partner with cross-functional team (e.g. clinical data management field teams) with query management data reviews and resolution

Supports assessments of current processes identifies opportunities and assists with improving process efficiency within and across related functional areas

Education and Experience Requirements:
Bachelors Degree or equivalent in related field
1-2 year of clinical research experience required

Additional Skills (Preferred):

Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System) eTMF (electronic Trial Master file) preferred.
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills
Good understanding of medical device regulatory requirements and documents device accountability and adverse events reporting
Strict attention to detail
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

Required Experience:

Apply Now