Medical Monitor

Medical Monitor

2 days a week in Burlington MA 3 DAYS REMOTE

Contract to hire

Job Overview
We are seeking a dedicated and compassionate Monitor to join our team.

Primary Responsibilities

• Work as primary Medical Monitor for assigned clinical trials and advise on trial related medical questions or problems during the conduct of the trial.

• Consult with internal and external stakeholders and experts to assist in the development and assist in the design and conduct of clinical trials including the drafting of protocols and amendments.

• Work closely with the clinical team and develop and/or edit clinical documents including Investigator Brochures, master Informed Consent Form and other related documents

• Work with the regulatory team and author and/or contribute to regulatory submissions, including, but not limited to, briefing documents, safety summaries, IDE/IDE supplements, PMAs.

• Develop and/or review operational, medical monitoring, and safety plans for awarded studies.

• Perform all activities in compliance with applicable regulations, policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.

• Bring a “can do” spirit to work and deliver on other responsibilities as assigned.

Professional Experience

• MD required.

• Minimum of 5 years’ direct experience in the medical device industry, preferably in a medical monitoring role, required.

• Proficient with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.

• Demonstrated ability to interpret and organize clinical and scientific data.

• Experience in type 2 diabetes and/or metabolic disorders and/or medical devices highly preferred

• Experience using electronic documentation management system preferred

Join us in making a difference in the lives of those we serve!

Job Type: Full-time

Pay: $100.00 - $150.00 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift
• Monday to Friday
• No weekends

Application Question(s):

• Please list your experience in type 2 diabetes and/or metabolic disorders and/or medical devices
• Please list your experience with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research
• Do you have your Doctor of Medicine?

Education:

• Doctorate (Required)

Ability to Commute:

• Burlington, MA 01803 (Required)

Work Location: Hybrid remote in Burlington, MA 01803

Salary : $100 - $150