Clinical Research Monitor (Remote)

Terumo Group; Aliso Viejo (CA); Remote; USD 70,000 - 100,000; Full time

Job summary

A leading company in the medical device industry seeks a Clinical Research Coordinator to manage investigational sites and ensure compliance with clinical trial protocols. The role demands strong communication skills, clinical knowledge, and a detail-oriented approach, offering an opportunity for significant engagement in trial management.

Qualifications

• Five years of general office experience with a minimum of one year of Clinical Research experience.
• Experience in the medical device industry and with regulatory requirements is preferable.

Responsibilities

• Participates in monitoring and administration of clinical trials.
• Manage multiple investigational sites and coordinate communication.
• Ensure compliance with protocol and reporting requirements.

Skills

Strong collaborative and communication skills

Knowledge of clinical procedures

Excellent written and oral communication skills

Computer literacy (MS Office)

Detail-oriented

Interpersonal skills

Education

Bachelor’s Degree or equivalent experience

Tools

MS Word

Excel

Outlook

Job description

Participates in the, administration, and monitoring of clinical trials. Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives. • Manage multiple investigational sites, for possibly same or multiple trials • Coordinate effective communication between investigational sites, study and data management teams, to include the study sponsor • Ensure investigational sites maintain requisite regulatory and study specific documentation and are aware of their obligations • Conduct pre-study, site initiation, interim monitoring, and study closeout visits and complete associated reporting requirements in accordance with GCP, company SOPs, and/or any other guidelines (sponsor, founder) • Perform source document verification, retrieve and review CRFs (and/or EDC) and verify completeness and accuracy at sites on a regular basis and/or according to the monitoring plan • Perform queries resolution in a timely manner • Generate study specific documentation including monitoring trip reports, telephone contact reports, site correspondence and expense reports • Ensure Serious Adverse Event (SAE) reporting according to project specifications • Review protocols for completeness and feasibility • Work under the supervision of the clinical trial manager to drive patient recruitment strategies and enrollment plans • Assist in writing clinical study reports by reviewing tables and listings generated from study data • Additional duties and responsibilities as assigned

• Strong collaborative and communication skills with demonstrated ability to work with physicians, site coordinators, vendors and others within the company • Knowledge of clinical procedures • Excellent written and oral communication skills, including computer literacy to include MS Office Word and Excel • Extremely detail-oriented • Good interpersonal skills • Ability to maintain strict confidentiality • Bachelor’s Degree or equivalent experience • Experience in the medical device industry (preferable) • Experience with Regulatory requirements for medical devices (preferable) • Five years of general office experience with a minimum of one year of Clinical Research experience • Experience with MS Word, Excel and Outlook • Ability to travel locally on occasion • Availability to work evenings and weekends intermittently as needed