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.
- Understand 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.
- Write clear, succinct and detailed clinical study, monitoring and technical summary reports.
- Effectively work and communicate with investigator and staff in a 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 Qualifications
- 2-3 years Clinical Research experience.
- Experience with 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.
Compensation
The anticipated range for this position is $65,000 - $95,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.
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.
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