Clinical Research Field Monitor

Masimo Corporation; Wes-Kaap; On-site; USD 80 000 - 92 000; Full time

Job summary

An established industry player is seeking a Clinical Research Field Monitor to ensure compliance in clinical projects. This role involves site monitoring, safety reviews, and documentation quality assurance. The ideal candidate will possess a strong clinical background and excellent communication skills, with a willingness to travel extensively. Join a forward-thinking company that values innovation and offers comprehensive benefits including medical, dental, and wellness programs. If you are passionate about clinical research and looking to make a significant impact, this opportunity is perfect for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Leave

Flexible Spending

Wellness Programs

Qualifications

• 2-3 years of Clinical Research experience required.
• Experience in site monitoring and knowledge of GCP essential.

Responsibilities

• Conduct site monitoring and ensure compliance with protocols.
• Complete monitoring reports and follow up on action items.

Skills

Clinical Research Experience

Site Monitoring

GCP Knowledge

Communication Skills

Microsoft Office Proficiency

Data Analysis Tools

Multi-Priority Management

Travel Willingness

Lifting Ability

Education

Bachelor's Degree in Science

CRA Certification Training

Tools

Microsoft Office

Data Analysis Tools

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 are conducted in accordance with Government Regulations (FDA, MDD, and International), Good Clinical Practices (GCP), and Department Operating Procedures (DOP).

Duties & Responsibilities

1. Conduct site monitoring: qualification, initiation, periodic monitoring, and close-out visits to ensure and document that the site is trained to follow study procedures per protocol.
2. Monitor safety reviews and adverse event reporting: for investigational medical devices to ensure adherence to GCP, FDA, and MDD regulations.
3. Ensure accountability: of Investigational Devices and study supplies when appropriate.
4. Perform monitoring activities: as per Clinical Investigational Plan, including verification of source documents and CRFs, maintaining site communications, and follow-up on issues.
5. Reporting and documentation: complete monitoring reports timely, follow up on open action items, and ensure sites identify issues and implement corrective actions.
6. Ensure documentation quality: accuracy, completeness, and proper organization of essential study documents.
7. Write reports: clear, succinct, and detailed clinical study, monitoring, and technical summaries.
8. Communication: work effectively with investigators and staff professionally and sensitively.
9. Travel: ability to travel extensively (up to 60%), locally, domestically, and internationally, including remote monitoring capabilities.
10. Physical tasks: ability to lift and carry up to 20 pounds for packing, shipping, and equipment setup.
11. Perform special projects: as requested.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• 2-3 years of Clinical Research experience.
• Experience in site monitoring activities.
• Knowledge of GCP in clinical studies.
• Excellent communication skills.
• Proficiency with Microsoft Office and data analysis tools.
• Ability to manage multiple priorities independently.
• Willingness to travel up to 60%.
• Ability to lift up to 20 pounds.

Preferred Qualifications

• 5-7 years of Clinical Research experience.
• Experience with medical devices and electronic data management solutions.
• Strong clinical background (e.g., respiratory therapy, nursing, pharmacology).
• Knowledge of FDA, ISO GCP, Medical Device Directive, and international regulations.
• Certification as a Clinical Research Associate or similar.

Education

Bachelor's degree in Science or a related field. CRA certification training is preferred.

Compensation and Benefits

The range is $80,000 to $XX,XXX, with potential for up to 10% annual bonus. Benefits include medical, dental, vision, life insurance, disability, paid leave, flexible spending, and wellness programs.

Physical Requirements / Work Environment

This role primarily involves office work with frequent sitting, standing, and walking. Use of computers and digital devices is daily. Must be able to lift 20 pounds and travel up to 60% locally and internationally. Reasonable accommodations can be provided for disabilities.