Clinical Research Field Monitor

Masimo Corporation; Mitchells Plain; On-site; USD 80 000 - 120 000; Full time

Job summary

An established industry player is seeking a Clinical Research Field Monitor to ensure compliance with clinical studies and regulations. This role involves extensive site monitoring, documentation, and communication with various stakeholders. The ideal candidate will have a strong background in clinical research, excellent communication skills, and the ability to travel frequently. Join a dynamic team that values innovation and quality in clinical practices. This position offers a competitive salary and a comprehensive benefits package, making it an exciting opportunity for those passionate about advancing healthcare through research.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Maternity Leave

Employee Assistance Program

Fitness Center

Wellness Clinic

Qualifications

• 2-3 years of experience in Clinical Research and site monitoring.
• Proficiency in Good Clinical Practices and regulatory compliance.

Responsibilities

• Conduct site monitoring and ensure compliance with study protocols.
• Document and report safety issues and monitoring activities.

Skills

Clinical Research

Good Clinical Practice (GCP)

Communication Skills

Data Analysis

Project Management

Education

Bachelor's degree in Science

CRA certification

Tools

Microsoft Office

Electronic Data Collection (Florence, REDcap)

Job description

Job Summary

The Clinical Research Field Monitor is responsible for compliance monitoring of assigned clinical projects undertaken in support of a given product line or marketing initiative. This position must ensure that all activities will be conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP) and Department Operating Procedures (DOP).

Duties & Responsibilities

• Conduct site monitoring (qualification, initiation, periodic monitoring and close out visits) to ensure and document site is trained to follow study procedures per protocol;


• Monitor safety reviews and adverse event reporting for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations;


• Ensure identification and reporting of safety issues (e.g. Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects, etc.);


• Ensure accountability of Investigational Devices and study supplies are performed, when appropriate to the study;


• Perform monitoring activities per Clinical Investigational Plan (e.g. verification of source documents and CRFs, maintain site communications, perform follow up activities on issues noted, etc.);


• Ensure complete reporting and proper documentation of monitoring activities (e.g. complete monitoring reports in a timely manner, follow up with sites to complete open action items, etc.);


• Ensure sites are identifying issues and implementing corrective and preventative actions to ensure inspection readiness;


• Suggest improvements to departmental procedures relating to GCP monitoring aspects;


• Understands and operate Masimo products, data acquisition systems, following best practices for execution of study protocol and use of equipment;


• Ensure essential study documents are accurate, complete, and properly organized and stored as quality records;


• Writes clear, succinct and detailed clinical study, monitoring and technical summary reports;


• Effectively work and communicate with investigator and staff in professional, sensitive and mature manner;


• Ability to travel extensively, approx. 60% of the time, locally, domestically and internationally; Travel requirement is subject to change based on business needs;


• Ability to monitor sites in person and remotely (as applicable)


• Be able to lift and carry up to 20 pounds in order to: pack, ship, move, unpack, set up and execute equipment for study at clinical site, and then repack and ship back to Masimo;


• Perform special projects as requested.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• 2-3 years Clinical Research experience


• Experience in conducting site monitoring (qualification, initiation, periodic monitoring and close out visits)


• Experienced with Good Clinical Practice (GCP) in conduct of clinical studies;


• Excellent written and verbal communication skills essential;


• Must be capable of interacting with all levels of management, coworkers, investigators and subjects;


• Proficiency with Microsoft Office, computer data acquisition, data analysis, graphing and plotting results and report writing;


• Ability to independently set and manage multiple priorities;


• Demonstrates advanced judgment and decision making ability in the execution / oversight of clinical studies;


• Ability to travel to data collection sites, local, domestic and international, may require up to 60% of time;


• Ability to lift and carry up to 20 pounds.

Preferred Qualifications

• 5-7 years Clinical Research experience


• Experience with medical devices


• Experience with electronic Trail Master Files and electronic data collection/management solutions (preferably Florence and REDcap)


• Strong clinical background (e.g., respiratory therapy, nursing, pharmacology, physiology)


• Excellent knowledge of FDA and ISO Good Clinical Practice (GCP) Regulations, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements


• Preferably certified as a Clinical Research Associate or an ACRP certified professional

Education

Bachelor's degree, preferably in Science or in a related field is required. CRA certification training is preferred. Combination of education and related experience will be considered in lieu of a bachelor's degree.

Compensation: The anticipated range for this position is $80,000 - $120,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, Voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center and Cafe. All benefits are subject to eligibility requirements.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Must be able to lift and carry up to 20 pounds in order to: pack, ship, move, unpack, set up and execute equipment for study at clinical site, repack and ship back to Masimo. Must be able to travel up to 60% of the time, both local and domestic (& possibly international), so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.