Spec 3, Clinical Research

MillenniumSoft Inc

Irvine, CA

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JOB DETAILS

SKILLS

Adverse Events, Clinical Data, Clinical Data Management, Clinical Information Systems, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Support, Clinical Trial, Clinical Trial Management, Communication Skills, Computer Skills, Cross-Functional, Detail Oriented, Document Management, Documentation, Documentation Review, External Audit, FDA (Food and Drug Administration), GCP (Good Clinical Practices), Healthcare Quality, Internal Audit, Interpersonal Skills, Logistics, Maintain Compliance, Medical Equipment, Microsoft Office, Presentation/Verbal Skills, Process Analysis, Process Development, Process Improvement, Regulations, Regulatory Compliance, Regulatory Requirements, Research Skills, Site Initiation, Standard Operating Procedures (SOP), Startup, Support Documentation, Team Player, Writing Skills

LOCATION

Irvine, CA

POSTED

1 day ago

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

Responsibilities include organizing, reviewing, and quality checking 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 cross functional 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:

Bachelor's 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

About the Company

MillenniumSoft Inc

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